News Alert

An independent committee has determined that Biogen and Eisai's lead Alzheimer's drug, aducanumab, is unlikely to meet the primary endpoints of two late-stage trials, spurring the partner companies to discontinue the studies in what one Wall Street analyst termed a "transformative failure" for Biogen. Despite a significant chance of failure, Wall Street pinned the bulk of Biogen's pipeline value on aducanumab. Not surprisingly, the biotech's shares were down more than 25% on the news, representing a loss of roughly $17 billion in Biogen's market capitalization. This has financial analysts speculating that an acquisition of Biogen is increasingly likely. Learn More

Foundation Medicine is subleasing 64,000 sq. ft. from PTC at 121 Seaport in Massachusetts, and it is likely the launch of a bigger Seaport real estate play, according to brokerage documents. The Cambridge-based company was also looking at Cambridge Crossing, but it has since zeroed in on the Seaport, particularly WS Development's Seaport Square, sources say. With city approval on a 7.7 million sq. ft. building plan, WS has several available blocks in its Seaport portfolio, depending on Foundation's space requirements, which published reports say include 300,000 to 400,000 sq. ft. of labs. Learn More

In a deal with $25M paid upfront and undisclosed "substantial milestones and royalties," Exscientia will use its artificial intelligence technology to help Celgene speed up the discovery of drug candidates for cancer and autoimmune diseases. This comes as artificial intelligence is gaining increased recognition for its potential to expedite drug discovery thus saving both time and money. Alert readers will recall that Exscientia has partnered with a number of leading biopharma firms including Roche, GSK and Sanofi to name just a few. Learn More

A North Carolina federal jury has determined that Puma acted with malice by falsely stating in an investor presentation that PPD founder Fred Eshelman had been "replaced as CEO of PPD" after being "involved in clinical trial fraud." As such, the court has granted Eshelman $15.85 million in compensatory damages and $6.5 million in punitive damages. The legal drama began in late 2015, when Eshelman proposed to increase the size of Puma's board from five to nine seats, nominating himself and three others of his choosing to take those new slots. Learn More

Merck has officially announced that the company management and the Joint Works Council have signed a comprehensive agreement applicable to the Darmstadt site. The aim is to secure the future viability of the company headquarters as a central science and technology hub and to further expand it. For this purpose, and with the agreement in hand, Merck has formally committed to invest $1.1 billion between now and 2025. "We believe in the tremendous potential of the Darmstadt site. There is no other Merck site in the world that has so much expertise combined at one location..." Learn More

Bayer is moving ahead with plans to sell its animal-health business according to people familiar with the matter. The business could fetch as much as $9 billion, though the sale won't start until the second quarter and valuations may change according to published reports. The German conglomerate is working with an accounting firm and advisers to prepare separate financial data ahead of the potential sale. Potential bidders are rumored to include KKR, Blackstone and Permira from the financial sector. No word yet on who, if any, among the biopharma's with interest in animal health plan to pursue a purchase of the business. Learn More

AbbVie has announced that the U.S. FDA has placed a partial clinical hold on all trials of its cancer drug Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the Venclexta arm of the late-stage study compared to those given a placebo alongside other treatment. Patients who are currently enrolled in studies and receiving the therapy may continue with the treatment, but no new patients should be enrolled in trials testing Venclexta for multiple myeloma until further analysis of the data is completed, the drugmaker said. Venclexta is jointly sold by AbbVie and Roche AG in the United States, while AbbVie sells it in other markets. Learn More

The Indianapolis City-County Council this week approved granting Eli Lilly a tax abatement worth $7 million over the next 10 years, even though several council members expressed concern about the proposal. The council voted 19-6 to approve Lilly's request, which is tied to the firm's pledge to spend $91 million on a building at its Lilly Technology Center on Kentucky Avenue that will house the company's biosynthetic human insulin production operations after a renovation. Opposition to the tax abatement came amid concerns that the planned investment will not create new jobs at the site. Learn More

Sanofi is working on a plan to find a new CEO in agreement and consultation with current chief executive Olivier Brandicourt, according to a spokesman for the French drugmaker. Sanofi has an age limit of 65 for its CEO and Brandicourt will be 65 in February 2021. Reports are that talks over the future of the group's management had intensified in recent weeks. Brandicourt was hired in 2015 to help revive the fortunes of France's biggest drugmaker and has been actively reshaping the business. Alert readers will recall his $20 billion deal with Boehringer-Ingelheim to move away from animal health and sale of its European generics business. Learn More

GW Pharmaceuticals has agreed to sell its Priority Review Voucher (PRV) to Biohaven for $105 million. In a related deal announced by Biohaven shortly thereafter, Royalty Pharma has agreed to provide up to $200 million to Biohaven for the purchase of the PRV from GW and general corporate use. The latter being specifically financial support for the expedited review of the Biohaven drug rimegepant Zydis and the associated NDA filing which is expected to occur in Q2' 2019. The deal is being financed with shares of preferred stock in Biohaven and future royalties. Learn More

Gulf Pharmaceuticals (Julphar) has announced that its acting chief financial officer has resigned. This comes just days after five members of the company's board of directors submitted their resignations. The series of recent high profile resignations comes amid challenging times for Julphar. Not the least of which being recently having to recall three of its products - Sedofan, Profinal and Cefuzime - "for not complying with product specifications". Alert readers will recall that Saudi Arabia banned the import of Julphar drugs into the Kingdom late last year putting severe financial pressure on the biopharma. Learn More

Modernizing clinical trials is an agency-wide priority. As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness. But these opportunities can be delayed or stymied by a clinical research enterprise that is often extraordinarily complex and expensive. Efforts to streamline medical product development based on advancing science can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective. Learn More

A group of influential scientists have urged that clinical use of CRISPR be put on hold in the wake of the Chinese gene-edited baby debacle. The call to suspend research on heritable germline DNA is reminiscent of the self-imposed moratorium when gene therapy first emerged in the 1970s. It is also a reminder that maintaining ethical standards is critical during the frothy times surrounding exciting novel medical technologies. Writing in the journal Nature, CRISPR specialists from seven countries have called for a global moratorium on heritable genome editing and the need for an international governance framework. Learn More

Sagent Pharmaceuticals, a division of Nichi-Iko Pharmaceutical Company, has announced the purchase of an FDA-approved manufacturing site in Raleigh, North Carolina, from Xellia Pharmaceuticals. The site is capable of approving both small-molecule drugs and biologics. While Sagent's chief executive officer (CEO), Peter Kaemmerer, Ph.D., said in a statement that while it intends to continue to manufacture some products for Xellia, the acquisition of the Raleigh site "will enable the production of lyophilized formulations of our future biosimilar product offerings." Learn More

Novartis is transforming its generics unit, a process that now includes a change in leadership. This week the Swiss pharma giant announced Sandoz CEO Richard Francis will step down at the end of the month. Francis took the helm of Sandoz in 2014, following 13 years at Biogen where he held various executive roles. Francesco Balestrieri, head of Sandoz's European division, will serve as interim CEO. In a statement, Francis pointed to the evolution taking place at Sandoz as the main reason for his departure. "I realize that this is a multi-year journey which I cannot commit to and therefore have decided that now is the right time to step down," he said. Learn More

The U.S. patent office this week rejected a filing by Alvogen for a review challenging patents on Celgene's blockbuster myeloma drug Revlimid. The Patent Trial and Appeal Board, a court run by the U.S. patent office, said it was denying Alvogen's petition for an inter-partes review on the patents of the drug. The court's decision helps in avoiding a potential issue as Bristol-Myers Squibb looks to finalize its acquisition of Celgene for $74 billion. Revlimid, Celgene's cancer drug that brought in $2.55 billion revenue in the fourth quarter of 2018, could still face the loss of exclusivity from 2022 onwards in the United States. Learn More

A federal judge is expected to rule soon in a case crucial to the longevity of Amgen's patent defenses for its top-selling biologic drug Enbrel, which the company has protected from biosimilar competition in the U.S. The district court case pits Amgen against Novartis' generic unit Sandoz, the maker of an Enbrel biosimilar approved in the U.S. in August 2016. Sandoz has yet to sell a single syringe of its copycat version, however, after Amgen won an injunction blocking the drug's production or sale. At issue are two patents Amgen licensed from Roche that could protect Enbrel from competition for another decade. Learn More

The U.S. FDA, in a warning letter to Pfizer's subsidiary Hospira, says that products made at the company's facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection last spring. According to the FDA, Hospira's microbiology lab did not accurately report microbial growth test results. During the inspection, the FDA requested that Hospira retest multiple batches of its products that were all reported as passing by the company. Each batch was found to be out-of-specification during retesting. Learn More

Insys Therapeutics announced this week that its auditor has raised doubts about the drugmaker's ability to continue as a going concern. The Arizona-based company says the auditor's opinion on the audited financial statements for the year ended Dec. 31, 2018 flags uncertainty in its ability to generate enough cash to meet its legal obligations and sustain operations. Insys said that while it is looking for ways to raise capital, it can provide "no assurances" on the success of its efforts or that it would resolve its liquidity issues and wipe out operating losses. Learn More

Tucked away on a U District side street, a 2-year-old nonprofit named SoundBio Lab caters to anyone who wants to experiment with molecular biology, microbiology and other life sciences that help us understand and alter genetic codes. Equipped with a menagerie of donated tools - used PCR machines, centrifuges, autoclaves and much more - and a mostly volunteer staff, SoundBio gives people of all ages and experience levels opportunities to learn and practice the essentials of a field that seems out of reach to many people, both intellectually and financially. Co-founder Zach Mueller believes biotechnology is the next era-defining industry. Learn More

Pall has partnered with Broadley-James to integrate and distribute Broadley-James' advanced single-use probe and flow cell pH sensors. With applications across upstream and downstream unit operations, the sensor will be integrated into Pall Biotech's single-use (SU) technologies, as well as other commercially available bioprocessing platforms. The novel SU pH sensors, currently in beta testing, leverage widely accepted glass electrochemical technology in a design that includes a calibrated buffer storage environment for the sensor to eliminate previous constraints during pre-integration of glass pH sensors into consumables. Learn More

Genentech says Amgen and Amgen Technology in Ireland, is infringing a protection certificate it enjoys on its patent for its product, Avastin. Amgen calls its biosimilar drug Mvasi. Genentech is seeking an injunction from the High Court's commercial division over what it believes is Amgen's intention to stock and/or import its own product in Ireland for the purpose of supplying the US market. It is also seeking a declaration that the use of its product infringes its patent, along with damages. Genentech says it learned from the U.S. FDA website that Amgen had been authorized by the FDA to carry out certain activities in Ireland in relation to Mvasi which if carried out would infringe its protection certificate. Learn More

An article published this week in STAT makes the argument that crowdfunding website GoFundMe should do more to prevent helping to raise funds for scientifically unproven and potentially dangerous medical treatments that are often packaged as legitimate clinical research and trials. However, the articles author notes that instead of trying to put a stop to these shady practices, GoFundMe is actually promoting them. In fact, the author shares first hand knowledge of no fewer than 400 crowdfunding campaigns, roughly 90% of which on GoFundMe, seeking donations for dubious stem cell interventions. Learn More

Chinese biopharma company BeiGene has agreed to pay Ambrx $10 million upfront to experiment with technology the biotech has developed in a bid accelerate BeiGene's search for new protein drugs for cancer treatment. Ambrx says its technology is able to incorporate "non-natural" amino acids into cells like E. coli and CHO, two cell lines commonly used for protein production. Alert readers will recall that Ambrx was acquired in 2015 by a consortium of Chinese investors including Fosun Pharma, Hopu Investments, China Everbright, and WuXi PharmaTech. Learn More

A bidding war significantly hiked up the price Roche paid for Spark Therapeutics, according to details on the deal's background revealed in a new filing with the Securities and Exchange commission. The document describes how Spark's path to being acquired began last May, when the gene therapy developer was looking to optimize its hemophilia A programs by finding a collaborator. Spark's search began with three candidates "reasonably likely" to have an interest in such a partnership: Roche, and two other global biotechnology and pharmaceutical companies referred to as Party A and Party B. Roche, however, was more interested in an acquisition. Learn More

From a top bunk in a 12-person prison cell in Fort Dix, N.J., Martin Shkreli is at work on a big second act. Wielding little more than a contraband smartphone, the disgraced pharmaceutical executive remains the shadow power at Phoenixus AG, the drug company that became a national lightning rod for jacking up the prices of rare drugs under its former name, Turing Pharmaceuticals AG. Mr. Shkreli still helps call the shots. A few weeks ago he rang up his handpicked chief executive during a safari vacation to fire him, according to published reports. Learn More

After spending $560 million to acquire Naurex and its lead drug Rapastinel in 2015, comes word that it has failed three studies and is expected to fail its fourth. Rapastinel was one of a handful of drugs embraced by biopharma several years ago in the hopes that they could work rapidly, taking hours, not weeks like many commonly used medicines, and improve the mood of people whose depression was severe. But the road has been tough. Another effort at developing an antidepressant, from the biotechnology firm Alkermes, ran aground at the U.S. FDA last year. Learn More

Accenture has acquired Enterprise System Partners (ESP), a consulting and manufacturing services provider that helps biopharma companies automate their operations. The acquired ESP will be integrated into Accenture's Accenture Industry X.0 practice, an arm that supports clients in the industrial sector with embracing digital transformation. The unit provides offerings such as Industry 4.0, Internet of Things, technology-led manufacturing excellence, robotics, and artificial intelligence. Alert readers will note that this latest acquisition of tribal knowledge specific to our industry is the latest instance of what is shaping up to be a trend. Learn More

Sartorius Stedim Biotech and Novasep have entered into a collaboration agreement in the area of chromatography and single-use bioprocessing. Novasep's established BioSC® platform and Sartorius' single-use technology will form the basis for the development of innovative chromatography systems. These systems, the focus of which will be the use of membrane chromatography as an alternative to batch and continuous resin-based chromatography, will seek to deliver higher productivity, smaller-scale operations, and increased robustness. Learn More

OxyContin maker Purdue Pharma is exploring filing for bankruptcy to address potentially significant liabilities from roughly 2,000 lawsuits alleging the drugmaker contributed to the deadly opioid crisis sweeping the United States, people familiar with the matter said this week. Filing for Chapter 11 protection would halt the lawsuits and allow Purdue to negotiate legal claims with plaintiffs under the supervision of a U.S. bankruptcy judge, the sources said. The potential move shows how Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the company of misleading doctors and patients about risks associated with prolonged use of its prescription opioids. Learn More

Eyeing a deeper pipeline of ophthalmology gene therapies, Biogen made public plans this week to acquire Nightstar Therapeutics for roughly $800+ million in cash. The acquisition gives Biogen access to Nightstar's pipeline of seven investigational therapies for inherited retinal diseases. The companies expect the deal to close sometime in the middle of 2019. Alert readers will recall that Biogen exited a collaboration with AGTC in December of last year after the latter saw one of its lead therapies post disappointing trial data. Learn More

Bristol-Myers Squibb's agreement to acquire Celgene for $74 billion is opposed by the biopharma's largest institutional investor. Wellington Management Group has made public its view that while it agrees Bristol should be active in deals that add new science and expand the company's revenue potential, Wellington "does not believe that the Celgene transaction is an attractive path towards accomplishing this goal." Wellington, which holds approximately 8 percent of Bristol shares, said the deal asks Bristol shareholders to accept too much risk. The investment firm added that achieving success following the deal could be more difficult than Bristol's management portrays. Learn More

A robotic pill that could put an end to painful drug injections, widely regarded as the "holy grail" of biotech, is one step closer to entering the market. Rani Therapeutics, a Silicon Valley company backed by Google's parent company Alphabet, has carried out its first human test of a capsule that eliminates the need for patients to insert a needle into their skin when administering diseases for chronic illnesses like diabetes. The pill travels from the mouth through the stomach and into the small intestine. There, the capsule dissolves and a tiny balloon inflates from a chemical reaction creating gas, which in turn pushes the tiny, dissolvable needle into the wall of the gut. Learn More

The U.S. FDA is backing early adopters of continuous manufacturing and other advanced manufacturing technologies through its Emerging Technology Team, and by requesting funding as part of the president's 2019 budget. The FDA has also issued draft guidance on the development and implementation of continuous manufacturing for brand, generic and over-the-counter drugs, which furthers a global effort among regulatory authorities to encourage adoption and implementation of the practice. Less than four years ago, only one drug made with continuous manufacturing had been approved. Now there are five products from four drugmakers, and more than 20 companies engaging with the FDA. Learn More

Novavax shares lost no less than 65 percent of their value this week after trial data showed one of its lead vaccines failed to prevent RSV disease, missing the main goal of the late-stage study. RSV, or respiratory syncytial virus, is highly contagious in children, and is the leading cause of infant hospitalizations in the United States. There is currently no vaccine approved to prevent the virus. The experimental vaccine, when administered to pregnant women, was unable to prevent medically significant respiratory tract infection caused by the virus in infants. Learn More

Akorn made public this week that the U.S. FDA had issued a number of observations related to a recent inspection of the company's manufacturing facility in Amityville, New York. Among the observations noted in the associated Form 483 dated February 13th, 2019 were the failure to keep records of maintenance, cleaning, sanitizing and inspection of process equipment. It should be noted that this recent Form 483 is not the first instance of FDA observations for the company in 2019. Akorn received a warning letter last month from the FDA for violations at its manufacturing facility in Decatur, Illinois. Learn More

Blackstone Life Sciences and Novartis have teamed up and launched Anthos Therapeutics, a biopharma company focused on developing therapies for patients at risk of heart disorders. Novartis licensed an experimental antibody, dubbed MAA868, to the new company and will hold a minority equity interest. Blackstone, meanwhile, will back Anthos with a cash infusion of $250 million and will be in charge of pipeline development. Anthos is based in Cambridge, MA, and is led by CEO John Glasspool, who previously ran Novartis's cardiovascular unit between 2004 and 2008. Learn More

Sarepta Therapeutics this week exercised an option to buy gene therapy startup Myonexus Therapeutics for $165 million. The company subsequently disclosed favorable results from the first program to come from the deal, a potential treatment for a form of Muscular Dystrophy. Sarepta first announced a partnership with Myonexus, a spinout of Nationwide Children's Hospital in Columbus, OH, in May 2018. In the deal, Sarepta paid Myonexus $60 million for the exclusive option to buy the company and its five experimental gene therapy programs upon getting a look at early human data. Learn More

The UK company RUNLABS, founded in 2018, plans to open its first facility where biotech companies can hire a package of lab space, lab services, offices, and even technicians in Paris. As of this writing the company has declined to disclose how payment for the use of the facilities will work, although they emphasize that it will be cost-effective for users. In addition to the French facility, RUNLABS is also looking for prospective sites in the UK, including a small area of London close to King's Cross station. Alert readers might recall that RUNLABs' is being sued by Alexandria Real Estate Equities, whose founder is the father of the RUNLABS founder, for misleading European investors by utilizing Alexandria's name and logo. Learn More

A federal jury this week upheld the validity of two patents held by Amgen on antibodies that work similarly to its cholesterol drug Repatha, setting back the rival team of Sanofi and Regeneron for the second time in a long-running court fight. While jurors in the case affirmed three of the five claims asserted by Amgen through the two patents, the verdict does not currently impact the U.S. availability of Sanofi and Regeneron's drug Praluent, which competes with Repatha. Begun in 2014, the simmering legal fight between the two camps looks likely to continue further still. Sanofi and Regeneron said they intend to file post-trial motions in the coming months in an effort to overturn the verdict and request a new trial. Learn More

The U.S. FDA this week issued a draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs. The 27-page draft guidance is part of the FDA's effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017. According to FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock, continuous manufacturing "transforms the traditional, step-wise manufacturing process into a single system that's based on modern process monitoring and controls. Learn More

Amicus has made public plans for a 75,000 sq. ft. Global Research and Gene Therapy Center in the heart of Philadelphia, Pennsylvania. The site, which is expected to be home to 200+ biologists, chemists and others, is expected to be available for move-in later this year. The company's current corporate headquarters in Cranbury, New Jersey will remain in place with the new center in Philadelphia serving as the headquarters of the company's science organization and gene therapy leadership team. Currently, a couple of dozen Amicus researchers have moved into a short-term space in West Philadelphia as they await the move. Learn More

GE has agreed to sell its biopharma business to Danaher for $21.4 billion. Danaher, perhaps best known to our industry for its ownership of Pall, gains bioprocess market leading brands AKTA, Hyclone, Wave, Xcellerex and more in the acquisition. The formal announcement of the sale makes a point of noting that the former GE group will operate as a standalone company within Danaher's life sciences business. No word yet on what, if any, antitrust concerns will need to be addressed. Alert readers will recall that the first mention of such a deal occurred back in April of last year, even going so far as to note a likely $20 billion purchase price. Learn More

Amid news of the Roche acquisition of Spark Therapeutics comes speculation among analysts of whose most likely to be next. Topping the list are Biogen and BioMarin, with the latter's smaller market cap making the prospect of an acquisition seemingly less daunting. As for likely suitors for either, some think that Pfizer, Merck and Johnson & Johnson may be considering such a move. However, Biogen and BioMarin are not alone, also being mentioned as possible acquisition targets are Eli Lilly, Bristol-Myers Squibb and Gilead, with particular attention being paid to the latter. Learn More

In a letter to the European Medicines Agency and EU27 Heads of Medicines Agencies, the European Commission's Directorate-General for Health and Food Safety detailed an exemption to certain batch testing requirements for drugmakers that currently perform batch testing in the UK. The letter comes roughly one month ahead of the UK's exit from the EU on March 30th, 2019. The exemption will give drugmakers who previously conducted batch testing in the UK time needed to move their batch testing operations to the EU in order to import their products. Learn More

Roche is nearing a deal to acquire U.S. biotechnology company Spark Therapeutics, the Wall Street Journal reported this weekend, citing people familiar with the matter. The deal for Spark could be announced today at a price tag of nearly $5 billion, but could still fall through, the Journal said, citing the unidentified sources. Spark's market value was just under $2 billion at Friday's market close. The newspaper reported there was at least one other unidentified bidder for Spark as of Friday. Learn More

Thirty-six years ago, the vice president of engineering for Bristol-Myers Squibb promised members of the Wallingford Rotary Club that the new world headquarters for pharmaceutical research and development would be a "signature building." Today, that signature building at 5 Research Parkway will most likely be demolished with redevelopment options uncertain. Bristol-Myers moved its research and administrative operation to Cambridge, Massachusetts and New Jersey in November. And while new owner Calare Properties continues to pay about $3 million annually in taxes, that amount will significantly decrease once the building is razed. Learn More

Merck & Co has announced that it will acquire Immune Design for nearly $300 million in cash to gain access to the company's immunotherapy programs. Seattle based Immune Design's pipeline includes late-stage immunotherapy technologies such as Glaas and Zvex. These treatments help activate the immune system to produce or expand specific immune cells to fight cancer and other diseases. No word yet as to what, if any, changes can be expected as a result of the acquisition which is expected to close early in the second quarter of 2019. Learn More

The Federal Trade Commission (FTC) this week announced a settlement resolving pending claims in three separate federal court antitrust lawsuits involving subsidiaries of Teva. The new order, which would last for 10 years, prohibits Teva from entering into the two most common forms of reverse payments: "(1) a side deal, in which the generic company receives compensation in the form of a business transaction entered at the same time as the patent litigation settlement; and (2) a no-AG commitment, in which a brand company agrees not to compete with an authorized generic version of a drug for a period of time," the FTC said. Learn More

Vical has made public its decision to halt a Phase 2 clinical trial begun roughly a year ago and initiate a restructuring as it attempts to conserve cash. At the time of this writing no details have been made public on the number of jobs that will be lost. Alert readers will recall that Vical originally announced plans for a strategic review in the Fall of last year after the company suffered two clinical trial failures. Those failures resulted in the company reducing its headcount by 50%. According to published reports, Vical is continuing its strategic review process begun last year and is considering near term strategic options. Learn More

Aradigm, which had been struggling after a setback with the U.S. FDA last year over its lead drug, has filed for Chapter 11 bankruptcy protection. This decision follows the harsh realization by the company's leadership team that long time investor Grifols was unwilling to provide further funding. In an SEC filing advising of the bankruptcy, the company notes that it has terminated its CEO and CMO while also accepting the resignations of five members of its Board of Directors. It is expected that, in accordance with the filing, Aradigm will place its IP and any physical assets up for sale shortly. Learn More

Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the U.S. the only country in the world to use such suffixes. The decision comes as Health Canada took into consideration the fact that all biologics, including biosimilars, have unique Drug Identification Numbers (DIN), which can help distinguish key characteristics of a product, including the brand name, manufacturer name, medicinal ingredient(s), strength(s), dosage form and route of administration. And in explaining its decision to take this path, Health Canada said it sought to avoid the complexity that the U.S. has seen and will continue to see. Learn More

Glenmark Pharmaceuticals has announced its decision to spin off the innovation business into a new company in the U.S. According to the plan, all innovative molecules in the pipeline, including preclinical assets and technology; the R&D centers in Switzerland, R&D center at Paramus in the U.S. and R&D center at Navi Mumbai, India related to the innovation business, and the biologics manufacturing facility in Switzerland along with all employees associated with innovative R&D will be part of the new company. The new innovation company, expected to be operating in 6 to 9 months, will be a wholly-owned subsidiary of Glenmark. Learn More

AveXis has announced plans to invest $60 million over the next two years to expand its presence in RTP, North Carolina. North Carolina Commerce Secretary Anthony Copeland joined local dignitaries and other officials at the North Carolina Biotechnology Center for the announcement of the expansion plan by AveXis, a gene-therapy firm. The company, which had been considering Dublin, Ireland as a possible location, plans to create upwards of 200 new jobs, the majority of which high paying in nature. Learn More

U.S. District Judge William Alsup met with skepticism arguments made by lawyers for JHL Biotech during a motion hearing for Genentech's civil case against the Taiwanese company. Genentech filed the civil suit seeking damages and an injunction in the U.S District Court for the Northern District of California after three former Genentech employees and an associate were indicted for stealing trade secrets for JHL in a criminal case. Judge Alsup, responding to the defenses argument for their client's innocence replied, "If that's your defense, good luck." Alert readers will recall that former Genentech employee James Quach is alleged to have downloaded trade secrets and provided them to JHL. Learn More

After 30 years of drug development, MedImmune will cease to exist as an industry name now that owner AstraZeneca has decided to retire the brand as part of ongoing restructuring efforts. Founded in 1988 under another name, MedImmune established itself over the next 15 years alongside Genentech and Genzyme as a leading biotech, producing drugs like RespiGam, Synagis and FluMist. AstraZeneca bought MedImmune in 2007 for $15.6 billion and quickly combined it with another one of the U.K. pharma's acquired companies to create a biologics R&D arm. Currently, MedImmune has 120 ongoing research projects and product candidates, accounting for nearly half of AstraZeneca's R&D portfolio. Learn More

Teva plans to close or divest 11 manufacturing sites this year, four more than the drugmaker shuttered in 2018 as its cost-cutting drive gathers momentum. This comes after a 2015 deal to buy Allergan's Actavis unit proved mis-timed, increasing Teva's presence in generics just as the market turned south. Since then, Teva has launched a major restructuring that's trimmed more than 10,000 jobs from the company's workforce. Part of that has come through reducing the number of manufacturing plants Teva operates from roughly 80 to closer to 60 although closures and divestments could continue. Learn More

5AM Ventures announced this week that it had closed the two funds - 5AM Ventures VI, worth $350 million, and 5AM Opportunities I worth $147 million. The firm, based in San Francisco and Boston, said 5AM Ventures VI will focus on building new biotech companies, while 5AM Opportunities I will target existing companies its portfolio with opportunities to invest additional capital. The money for the funds was raised from corporate and public pensions, endowments, foundations, family offices and funds-of-funds. Learn More

Charles River Labs has signed a binding offer to acquire Citoxlab for roughly $510 million in cash. The acquisition is expected to close in the second quarter of 2019, subject to labor consultations, regulatory requirements, and customary closing conditions. Citoxlab is a premier, non-clinical contract research organization (CRO) with operations in Europe and North America, the proposed acquisition of Citoxlab would further strengthen Charles River's position as the leading, global, early-stage CRO by expanding its scientific portfolio and geographic footprint, which would enhance the Company's ability to partner with clients across the drug discovery and development continuum. Learn More

Biotech opportunities for foreign companies doing business in China may be short-lived as the country builds its domestic biosimilars industry, according to a report released this week by U.S Senator Marco Rubio. The report, "Made in China 2025 and the Future of American Industry," was issued through the U.S. Senate Small Business and Entrepreneurship Committee, which Rubio chairs. According to the report, recent reforms by China's National Medical Products Agency to streamline drug approvals and align with international standards on production, drug assessments and clinical data, are a prelude to a long-term strategic goal unfavorable to U.S. biopharma. Learn More

A U.S. patent board declined to review key patents held by Celgene on its top-selling multiple myeloma drug Revlimid, denying petitions this week from Indian drugmaker Dr. Reddy's that sought to begin a process to overturn them. The decisions make the prospects of a cheaper copycat entering the U.S. market before 2022 more remote, although ongoing district court litigation between Celgene and Dr. Reddy's still presents a risk to the biotech's sales forecasts for the blockbuster drug. The victory, while not unexpected, is likely to increase investor confidence in Bristol-Myers Squibb's decision to buy Celgene for $74 billion. Learn More

In an exclusive interview with BioSpace, Iovance Chief Executive Officer Maria Fardis says the company's goal is to add headcount to support its growth strategy. The company currently has about 100 full-time employees, but Fardis said Iovance is looking to expand, particularly as the company prepares for potential commercialization of its lead candidate lifileucel (LN-145). The headcount growth is expected to be in the company's Tampa, Florida location, where it has its manufacturing facility. Fardis said it is the Florida site that will see the most growth in headcount. Learn More

In exclusive reporting by Endpoints we learn that current MedImmune execs have been spreading the word that the subsidiary will soon end its 11-year run as a separate organization as the company reorganizes under two previously announced main R&D banners, splitting MedImmune's large molecule work between two disease-specific organizations. The reorganization has sparked intense rumors about which research groups will come out on top and which will be relegated to the sidelines. Learn More

A federal magistrate judge has ordered AbbVie to promptly comply with an earlier command that it turn over documents related to an alleged campaign aimed at stymieing biosimilar competition to its $20 billion immunosuppressant Humira, warning against further efforts to throw "wrenches into the gears" of its high-stakes patent case against Boehringer Ingelheim. This latest order comes after AbbVie failed to comply with the judges previous order to turn over all pertinent documents and is alleged to have engaged in efforts to mislead the court. Learn More

Aurobindo has announced the completion of its deal to acquire Apotex's commercial operations and certain supporting infrastructure in five European countries. Alert readers will recall that the company had inked a binding agreement on July 14, 2018, to acquire five of Apotex' European businesses, including infrastructure, personnel, products, certain established trademarks, marketing authorizations and dossier license rights in Poland, the Czech Republic, the Netherlands, Spain and Belgium. Learn More

It has taken nearly six years, detours for bitter legal challenges, and tens of millions of dollars in legal fees, but the foundational CRISPR-Cas9 patent for which the University of California applied in March 2013 will soon be granted, according to documents posted by the U.S. Patent and Trademark Office. Thereby throwing yet another monkey wrench into genome editing's tangled IP landscape. The '859 patent, as aficionados fondly call it, covers the use of CRISPR, in particular a single molecule of RNA acting as a genome-sniffing bloodhound, paired with the Cas9 DNA-cutting enzyme to edit genomes. The patent office's "notice of allowance" means that the patent will be issued in about six to eight weeks. Learn More

Boehringer Ingelheim Animal Health will create 225 jobs and invest more than $120 million in the state of Georgia's Gwinnett, Clarke, and Hall counties. These monies are expected to increase manufacturing capacity and optimize Boehringers numerous R&D initiatives. The company, which announced back in November of last year plans to move its North American headquarters from Missouri to Duluth, is adding more than 100 new jobs at its manufacturing and research and development facility in Athens; and more than 50 jobs at the company's Gainesville manufacturing facility. Learn More

Gossamer Bio, the San Diego-based biotech founded by former Receptos executives, has raised $276 million in its initial public offering. A total that puts the young biotech in a rare class among biopharma's that have gone public in recent years. The Gossamer IPO comes just over one week after the company asked the SEC to accelerate the review of its paperwork to allow it to go public before the date its stock offering would have automatically become effective under the fixed-price path and ahead of any prospective second government shutdown. Learn More

The key patent protecting Biogen's top-selling drug in the U.S. is now under review by patent officials. Should they strike down the patent, about half of the big biotech's stateside revenue could be at risk. Rival drugmaker Mylan filed a petition last July with the U.S. Patent and Trade Office requesting an inter partes review (IPR) of patent '514, which covers a method of treatment for Biogen's Tecfidera through 2028. In a decision filed this week, the office concluded Mylan has a "reasonable likelihood of success" in proving at least one of the 20 claims in '514 is unpatentable, and therefore instituted an IPR. Tecfidera has been Biogen's biggest product since 2014. Learn More

Buried deep in this week's fourth-quarter financials report from Sanofi is a slide detailing R&D pipeline changes, making it clear that the French group has been paying attention to recent trends in immuno-oncology, but also containing a few surprises. Eliminated are 13 development programs and no fewer than 25 research-stage projects bringing the total number of programs cut to 38. Sanofi is not along in the culling of its pipeline this week, Lilly announced the elimination of three programs and GSK announced the elimination of six programs. Like Sanofi, they too seem increasingly focused on their efforts specific to oncology. Learn More

Seres Therapeutics was one of the first microbiome companies to form, back in 2010. And the Flagship Pioneering company was the first to go public. But this week, faced with the challenges of developing a fundamentally different kind of therapeutic, the company said it is axing 30 percent of its staff, around 30 employees and contractors, and that David Cook, its chief scientific officer, will be replaced by Matthew Henn, who was head of discovery and microbiome R&D. The layoffs will be in research, manufacturing, and administration, and Mr. Cook will act as a consultant. Learn More

A U.S. jury has ordered Takeda's Baxalta unit to pay Bayer $155.19 million for infringing a patent held by the latter related to a Baxalta hemophilia treatment, court records made public this week show. Jurors in the federal court in Wilmington, Delaware, reached their verdict on the seventh day of a trial after rejecting Baxalta's argument that the June 2016 patent on the treatment, Adynovate, was invalid. Bayer said the infringement arose from Baxalta's exclusive license agreement with Nektar Therapeutics, which had done research with Bayer and knew about the patent, including through litigation in Germany. Learn More

GlaxoSmithKline will pay Germany's Merck KGaA as much as $4.2 billion to get access to a promising immune-oncology treatment that the drugmakers see as a key to bringing the next wave of cancer therapies to patients. The collaboration, which includes an upfront payment of $342 million, is the latest step in GSK CEO Emma Walmsley's effort to rebuild the U.K. company's position in oncology. For Merck, it helps fulfill CEO Stefan Oschmann's goal to bring in expertise and funds needed to develop and market innovative treatments. The experimental drug at the center of the German company's agreement with Glaxo, M7824, is in a pivotal trial against Keytruda for lung cancer. Learn More

Roche and Forma Therapeutics have filed WARN notices with Massachusetts informing them of impending layoffs. According to the Massachusetts Worker Adjustment and Retraining Act (WARN) weekly report, Forma Therapeutics plans to cut 61 employees over the course of the next year. The cuts are slated to begin in March and be completed by the end of March 2020. Also included in the weekly report was Roche, which will lay off 55 employees at its CPS-Center of Excellence Hematology in Brighton, Mass. The layoffs of those employees will begin in April of this year and the final job cut will be completed by April 2020, according to the notice. Learn More

When construction is completed this month, 704 QO in the Gaithersburg Life Sciences Cluster will offer ready-to-occupy lab/office spaces for companies of all sizes. What really makes this new building stand out isn't just the fully customizable individual lab units, but the suite of amenities that are tailored to the specific needs of emerging life science companies. Lab-friendly amenities include an autoclave, glass wash station, sink, and ice maker for use by all of the tenants. They even have an onsite self-service supply store managed by VWR. It will stock lab supplies and disposables such as gloves, goggles, and pipettes to make sure tenants have everything they need at their fingertips. Learn More

A lot of ink has been spilled on the controversial random suffixes that the U.S. FDA is now tagging on the end of the nonproprietary names of biologics and biosimilars. And now Sanofi is joining the chorus against the four-letter suffixes, saying it will not submit suffixes for two of its vaccines and claiming the addition of suffixes to vaccine labels could cause confusion among health care providers and negatively impact public health. The FDA has said it will go back and add the meaningless suffixes to all previously approved biologics (all biosimilars currently have suffixes), though the agency has yet to begin this process. Learn More

Novum Pharma has filed for bankruptcy and plans to sell its assets, saying it has faced a series of financial and operational challenges. The Chicago-based drugmaker, which encountered public scrutiny a few years ago for hiking the price of its skin medications, filed for chapter 11 in the U.S. Bankruptcy Court in Wilmington, Delaware, and will sell the intellectual property for its product lines, along with other assets. The company is attributing its challenges in part to ongoing scrutiny surrounding pricing for its products. Learn More

Immuno-oncology company Torque and Thermo Fisher Scientific have entered into a collaboration to build a dedicated Slipstream manufacturing facility for high-efficiency production of Torque's Deep-Primed T cell immunotherapies. Buildout of the Torque/Thermo Fisher manufacturing facility has begun, and the companies anticipate processing patient cells by the end of 2019. The Slipstream platform will initially be used in the clinical development of Torque's lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors; and afterward by TRQ-1201, also for solid and hematologic tumors. Learn More

The U.S. FDA has announced that Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND), has decided to leave the FDA and will depart February 22nd, 2019. Christl is moving to Amgen to become the executive director of global regulatory and R&D policy beginning March 11th, 2019. A frequent speaker at industry and other conferences, Christl "was instrumental in policy development and the interpretation and implementation of the Biologics Price Competition and Innovation (BPCI) Act for CDER and FDA, which has led to 17 FDA approved biosimilars to date," according to CDER Director Janet Woodcock and OND Director Peter Stein. Learn More

Apceth Biopharma has announced that Hitachi Chemical will enter into an agreement to acquire all shares of the company. This acquisition is expected to close in April 2019 but as of this writing no financial details have been made available. Founded in 2007, apceth is a pioneer in cell and gene therapy and has developed into a leading European CDMO for Advanced Therapy Medicinal Products (ATMPs). By acquiring apceth, Hitachi Chemical gains state-of-the-art facilities in Munich, Germany from which to leverage for an increased presence in Europe. Learn More

International consultancy Pharmalex has seen a major jump in the number of drug manufacturers moving parts of their business from Britain to Ireland. The volume of transfers in the industry between the two countries is putting the capacity of the Irish pharmaceutical industry under pressure, said John Cahill, a director at the company's Irish office. In the past year it has been involved in more than 30 individual Brexit-related projects involving a transfer of operations from entities in the UK to Ireland, said Cahill. The projects have included the transfer of manufacturing, testing, batch release responsibilities and marketing authorization responsibilities between the two countries. Learn More

Lonza will promote the head of its fastest-growing division to become the company's new chief, announcing this week that its CEO of seven years, Richard Ridinger, will retire effective March 1, 2019. Marc Funk, currently chief operating officer of Lonza's pharma and biotech division, will succeed Ridinger as head of the contracting giant. Funk has led Lonza's biopharma unit since 2014, growing the business from sales of 1.4 billion Swiss francs then to 3.1 billion Swiss francs last year. All told, Lonza contracted on 865 small- and large-molecule drug programs last year. Learn More

Johnson & Johnson this week announced a worldwide collaboration and license agreement with MeiraGTx to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio. Under the terms of the agreement, Janssen will pay MeiraGTx $100 million up front in cash. Janssen will gain exclusive options to develop other preclinical treatments for other types of inherited vision loss. MeiraGTx is eligible for up to $340 million in various milestone payments, as well as royalties on sales of any projects. Janssen is paying for clinical development. Learn More

The latest flare-up over the cost of medicines is taking place in Switzerland, where a nonprofit group has formally asked the government to issue a compulsory license for a Roche breast cancer treatment, apparently the first time such a move has occurred in the wealthy country. In a letter to the Swiss health minister, Public Eye claims that "excessive pricing" for the Perjeta medication - which is part of a combination treatment that includes another Roche drug - is "undermining" the ability of the government to ensure "the entire Swiss population continues to benefit from affordable access to lifesaving treatments in a sustainable manner." Learn More

Roche Holding and partner AC Immune SA called a halt to two late-stage clinical trials of their crenezumab drug for early Alzheimer's, the latest in a string of failures to find a treatment for the progressive brain disease. The recent announcement comes after an interim analysis indicated it was unlikely to be effective. Shares of AC Immune fell 65% on the news. Drugmakers such as Eli Lilly, AstraZeneca Plc and Johnson and Johnson have all abandoned trials testing their associated experimental drugs. Learn More

CBRE has announced that biotech company Akouos has assigned a lease on 37,500 square feet of lab space on the second floor at 645 Summer Street in Boston's Seaport District. 645 Summer Street is part of a multi-building complex known as Pappas Commerce Center located in the heart of Boston's Seaport District. The cutting-edge flex building is designed to meet the expectations of Boston's new economy. With a significant influx of high-profile companies looking for next-generation flex space, 645 Summer Street can accommodate both office and light lab tenants. Learn More

ASLAN made public this week plans to reduce its headcount by 30% and announced the retirement of the company's CMO. The savings will be used to focus its resources on its lead clinical programs. In related news, Aduro Biotech has reduced its current workforce by roughly 37% as it redirects strategic resources to its cancer drugs now in clinical development. Both companies are attributing the recent job cuts to corporate restructurings necessary to realize the potential of their lead drug programs. Alert readers will recall that Aduro has development partnerships with industry leaders Novartis, Lilly and Merck. Learn More

Strides Pharma has entered into an arrangement to acquire a 100% stake in Vensun Pharmaceuticals. Vensun was founded in 2011 with an asset-light partner-driven business model to develop products for the U.S. generics markets. It previously entered into a partnership with Shasun Pharma, now Strides, for a range of difficult to develop products on a 50:50 profit share arrangement. Vensun has a strategic focus on niche ANDAs with a portfolio of 16 commercialized ANDAs, four of which are partnered with Strides and constitute a significant part of Vensun's current revenues. Learn More

The road to potential approval for Voyager Therapeutics' experimental gene therapy for Parkinson's disease got a bit longer, and more expensive, last year. So this week the company cut a deal with Neurocrine Biosciences to bankroll the journey-and forfeit some of the financial upside for the product, known as VY-AADC. Neurocrine has agreed to pay Voyager $115 million in cash and buy $50 million worth of the Cambridge, MA, company's shares. In return, Neurocrine will gain rights to Voyager's VY-AADC, an experimental gene therapy for Parkinson's disease, and pick up the tab for late-stage clinical development. Learn More

The leading life sciences organizations in Massachusetts this week announced the start of Project Onramp, a new program that matches talented, first-generation students from low-income backgrounds with well-paid summer internships. The internships are intended to serve as a stepping-stone to a rewarding career for a talent pool that has typically had difficulty gaining access to the burgeoning life science industry. It will also help growing Massachusetts biotechnology companies fill the additional 12,000 positions estimated to be created by 2023. Learn More

MorphoSys' lawsuit against Janssen and Genmab in the U.S. District Court of Delaware has resulted in three of the formers patents recently being ruled invalid. The patents in question, numbers 8,263,746; 9,200,061 and 9,758,590 were named in a Summary Judgement of invalidity filed by Janssen and Genmab. As a result of this decision, the jury trial scheduled for February 2019 to consider defendants' alleged infringement and the validity of the MorphoSys patents will now not take place. For their part, MorphoSys's management has expressed disappointment in the ruling and is understood to be considering a number of options including the filing of an appeal. Learn More

FDA staff began returning to paid work this week after the longest government shutdown in U.S. history. However, with the temporary funding set to expire on February 15th, 2019 and President Donald Trump skeptical a deal can be reached, the agency may be plunged back into a shutdown in less than three weeks. FDA Commissioner Scott Gottlieb says he is working to get back pay to staff by the end of the month and is otherwise taking actions to ensure they and the agency can get back to normal as soon as possible. But Gottlieb thinks it will take time to recover from the 35-day shutdown. Learn More

Allergan and the Saint Regis Mohawk Tribe have asked the Supreme Court of the United States to rule that the Tribe can use its sovereign immunity to fend off challenges by makers of low-cost generic copies of the best-selling prescription eyedrops, Restasis. Alert readers will recall that in September of 2017 Allergan transferred patents for Restasis to the tribe, paying $13.75 million upfront and committing to $15M a year as long as the patents remained valid. At the same time, the tribe gave Allergan "the sole and exclusive right" to manufacture and market the drug in the United States for uses approved by the FDA. Learn More

A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Civica Rx initially expected to offer 14 drugs in 2019. Within three-to-five years, it aims to offer up to 100 generic medicines critical to the everyday function of its member hospitals. Since the start-up of Civica Rx was announced last January, it has raised more than $160 million from its members, which together represent about 800 hospitals. Learn More

Roche's Genentech unit has appointed Alexander Hardy to serve as CEO. He initially joined South San Francisco, CA-based Genentech in 2005 and worked there in several senior management roles until 2014 when he became head of Asia Pacific for Roche's pharmaceuticals division. Hardy is currently Roche's head of global product strategy. At Genentech, he will succeed Bill Anderson, who was recently named Roche Pharmaceuticals CEO. Hardy will start his new role at Genentech in South San Francisco on March 1st of this year. Learn More

Johnson & Johnson ranked as the No. 1 biopharma on The World's Most Admired Companies, according to an annual Fortune list released this week. To create its 2019 list, the magazine compiled survey responses from executives, directors and analysts who rated companies within their industries based on nine criteria. For biopharma's, J&J finished first in each of the criteria, which included long-term investment value, innovation, global competitiveness and social responsibility. Non-biopharma execs and analysts also reported a positive view of J&J, helping it to snag the No. 17 spot on a separate "All-Stars" list of the 50 most admired companies across industries. Learn More

In another setback in the lucrative lung cancer market, Bristol-Myers Squibb said this week that it is withdrawing its application with the U.S. FDA to use its cancer immunotherapy blockbuster, Opdivo, in combination with Yervoy, a second Bristol drug, for some patients with previously untreated non-small cell lung cancer. The announcement comes just weeks after BMS said it would acquire Celgene for $74 billion. Learn More

Vertex this week terminated the employment of its chief operating officer and interim chief financial officer, Ian Smith, citing "personal behavior" that violated its code of conduct. The termination is effective immediately and is unrelated to the company's financial and business performance, Vertex said. Paul Silva, the company's corporate controller and chief accounting officer since 2008, has been appointed interim CFO, while the company conducts a search for a permanent replacement. The decision followed an investigation conducted with the help of an independent external counsel WilmerHale, the Boston-based biotech company said. Vertex did not specify what the violations were. Learn More

uBiome, which late last year secured $83 million in additional financing, is reportedly laying off 55 employees, roughly 10% of its workforce. This comes as the company takes steps to realign operations so as to better pursue "drugs and partnerships with drug developers". In related news, local media is reporting that Theravance has eliminated roughly 50 positions associated with its drug Vibative. This follows the recent sale of Vibrative to Cumberland Pharmaceuticals. Those persons impacted included early stage researchers and associated support staff. Learn More

The U.S. Supreme Court this week refused to revive Helsinn Healthcare's patent on the drug Aloxi in a victory for Teva which launched a generic version of it last year. The nine justices unanimously upheld a lower court ruling that had canceled Helsinn's patent on Aloxi for violating a provision in U.S. patent law that forbids sales of an invention before applying for a patent. Teva began selling its generic version of the drug in March 2018 after convincing the lower court to invalidate the patent. The ruling could make it easier to cancel key patents, especially among smaller drugmakers. Learn More