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BioCentury Extra
As published Wednesday, January 18, 2017 5:11 PM PST

  • Lilly acquiring CoLucid

    Eli Lilly and Co. (NYSE:LLY) is acquiring migraine company CoLucid Pharmaceuticals Inc. (NASDAQ:CLCD) for $46.50 per share in cash, or about $960 million. The price is a 33% premium to CoLucid's close Tuesday of $34.90, before the deal was announced. The companies expect to close the deal this quarter.

    CoLucid expects data next half from the Phase III SPARTAN study of lasmiditan (oral COL-144) to treat acute migraine. The company hopes to submit an NDA to FDA for the candidate in 2018.

    In September, CoLucid said both doses of lasmiditan met the primary endpoint in another Phase III trial, SAMURAI, to treat acute migraine (see BioCentury Extra, Sept. 6, 2016).

    CoLucid gained rights to lasmiditan from Lilly in 2005. The compound is a selective agonist of serotonin (5-HT1F) receptor.

    CoLucid gained $11.35 (33%) to $46.25 on Wednesday.

  • Takeda, Ovid team to develop epilepsy candidate

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Ovid Therapeutics Inc. (New York, N.Y.) partnered to develop the Japanese pharma's TAK-935. Takeda has completed four Phase I studies of the candidate, and the partners expect to begin a Phase Ib/IIa study this year to treat rare pediatric epileptic encephalopathies, including Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex.

    TAK-935 inhibits cytochrome P450 family 46 subfamily A polypeptide 1 (CYP46A1; CH24H). The target may play a role in epilepsy by modulating the NMDA receptor, contributing to over-activation of the glutamatergic pathway. BioCentury's BCIQ database contains no other CH24H inhibitors in development.

    Also according to BCIQ, the deal is the first 50/50 cost- and profit-sharing partnership in which a biotech gained global rights to a pharma asset since the database began recording deals in 2009. Ovid is to lead clinical development and has commercial rights in the U.S., Europe, Canada and Israel. The partners said an interdisciplinary team from both companies would guide development.

    Takeda is to lead commercialization in Japan, and may opt to lead elsewhere in Asia and in certain other territories. Takeda received an undisclosed equity stake in Ovid and is eligible for milestones. The partners may expand the collaboration to additional orphan CNS indications.

    Ovid's strategy includes in-licensing and repurposing molecules to treat rare CNS disorders (see BioCentury, April 20, 2015).

  • Boehringer's biosimilar Humira under FDA, EMA review

    Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA and EMA accepted for review regulatory applications for BI 695501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). In October, Boehringer said the biosimilar met the primary endpoint of a Phase III study by showing equivalence to Humira in patients with rheumatoid arthritis.

    One other biosimilar of Humira has FDA approval, but is not yet marketed. In September, FDA approved Amjevita adalimumab-atto (ABP 501) from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Sept. 23, 2016).

    AbbVie has claimed its Humira patents will keep rivals off the U.S. market until 2022, although Amgen has said it could launch Amjevita as soon as this year (see BioCentury, July 25, 2016).

    An MAA for SB5, a Humira biosimilar from Samsung Bioepis Co. Ltd. is under EMA review. The company is a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung Group (Seoul, South Korea) (see BioCentury Extra, July 18, 2016).

    At least three other biosimilars have shown equivalence to Humira in Phase III studies. They include CHS-1420 from Coherus BioSciences Inc. (NASDAQ:CHRS); M923 from Momenta Pharmaceuticals Inc. (NASDAQ:MNTA); and FKB327 from Fujifilm Kyowa Kirin Biologics Co. Ltd., a JV between Fujifilm Holdings Corp. (Tokyo:4901) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151). Momenta hopes to submit M923 to regulators this year.

    Humira is approved for several other autoimmune indications beyond RA. Boehringer declined to name the indications for which it is seeking approval of the biosimilar, or divulge when it expects decisions from FDA and EMA.

    Adalimumab is a mAb against tumor necrosis factor (TNF) alpha.

  • Management tracks

    Cancer company Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) named Richard Peters president and CEO, effective Feb. 6. He was SVP and head of global rare diseases at the Genzyme unit of Sanofi (Euronext:SAN; NYSE:SNY).

    Fibrosis and inflammation company Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) named Walid Abi-Saab CMO, effective March 1. He was group VP of global clinical development and therapeutic area head of gastrointestinal, endocrinology and metabolism at Shire plc (LSE:SHP; NASDAQ:SHPG).

    Cancer and vaccines company Bavarian Nordic A/S (CSE:BAVA) promoted Henrik Birk to COO, a newly created position, from SVP of strategy, people and organization.

    Women's health company ObsEva S.A. (Geneva, Switzerland) named Timothy Adams CFO. He was EVP and CFO at Demandware Inc. (Burlington, Mass.).

    Musculoskeletal and anti-infectives company Summit Therapeutics plc (LSE:SUMM; NASDAQ:SMMT) named David Roblin COO and president of R&D. He is to begin in April on an interim basis, and become full-time in June. Roblin was COO and director of scientific translation at the Francis Crick Institute (London, U.K.).

  • NEA sets $3B target for 16th fund

    New Enterprise Associates has set a $3 billion target for its New Enterprise Associates 16 fund, according to an SEC filing. The firm, which invests in both technology and healthcare, did not respond to inquiries.

    NEA closed its fifteenth fund in April 2015 with $2.8 billion, plus $350 million for an adjunct fund (see BioCentury, Jan. 19, 2015 and BioCentury Extra, April 15, 2015).

  • Financial tracks

    H.C. Wainwright hired John Chambers as president and head of investment banking. He was vice chairman and head of healthcare investment banking at Roth Capital Partners.

    Lilly Asia Ventures named Darren Ji venture partner. He was VP and global head of partnering for Asia and emerging markets at Roche (SIX:ROG; OTCQX:RHHBY).

    Bain Capital Ventures named Yumin Choi managing director for healthcare. Choi was a general partner at HLM Venture Partners.

  • Collins set to resign as NIH director

    NIH Director Francis Collins will resign his post if he is not asked to stay by noon on Jan. 20, spokesperson Renate Myles told BioCentury. The agency named Collins director in August 2009.

    Principal Deputy Director Lawrence Tabak would become acting NIH director if Collins resigns, Myles said.

    Last month, Republican chairs of the U.S. Senate and House committees responsible for oversight of federal biomedical research urged President-elect Donald Trump to retain Collins as NIH director (see BioCentury Extra, Dec. 5, 2016).

    Prior to Collins' appointment, Raynard Kington was acting NIH director from October 2008 to August 2009. He was the agency's principal deputy director before and after his stint as acting director (see BioCentury Extra, Oct. 30, 2008).

  • Price bobs and weaves on drug prices

    President-elect Donald Trump's nominee for HHS secretary, Rep. Tom Price (R-Ga.), dodged questions Wednesday about negotiation of drug price controls. Trump recently called for HHS to negotiate Medicare drug prices, a policy that Price has opposed in the past (see BioCentury, Jan. 16).

    At a hearing of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, Sen. Bernie Sanders (I-Vt.) asked Price if he and Trump would support legislation to give HHS power to negotiate drug prices. Price responded that the "issue of drug pricing and drug costs is one of great concern," but would not commit to supporting negotiation.

    "Trump will be my boss," Price said when pressed on the issue by Sen. Tammy Baldwin (D-Wis.). "Following discussion with everyone involved, I will carry out his ultimate wishes. Following the process I will act. We need to find solutions to gaining access to needed medication, and one of those might be to change ways we arrive at drug prices."

    Baldwin also pushed Price for his views on a proposal to require drug companies to provide detailed justifications of price increases. The nominee said "there is a merit to transparency" about price hikes.

    Democrats accused Price of exploiting his position in Congress to make unethical stock purchases in biomedical companies that benefited from his legislative activities. Price said some purchases for which he was criticized were made by a stock broker without Price's prior knowledge. Price acknowledged investing in Innate Immunotherapeutics Ltd. (ASX:IIL), including his participation in a private placement, but denied an accusation from Sen. Al Franken (D-Minn.) that it was a "sweetheart deal."

    The HELP Committee described Wednesday's hearing was a "courtesy hearing." It will not vote on Price's nomination.

    Price's position on Medicare drug pricing, as well as allegations of unethical investment activities, are certain to be raised at his Senate Finance Committee confirmation hearing, which is scheduled for Jan. 24.

  • FDA releases documents on off-label communication

    On Wednesday, FDA released two new documents that address off-label communications about medical products. A draft guidance outlined questions and answers regarding communication with payers about healthcare economic information, including information concerning unapproved uses of medical products. A separate memorandum described the agency's position on sharing information about off-label use of approved drugs.

    In the guidance, FDA described "truthful and non-misleading" healthcare economic information that is acceptable for product sponsors to share with payers or formulary committees. The agency said it is acceptable to share information that "relates to" a product's approved indication, with some variance allowed about factors such as dosing, patient subgroups, and practice settings beyond what is included in the product's label. The guidance said certain other information, such as analyses of patient populations not included in a label, would not be acceptable.

    The document said economic analyses provided to payers should specify the type of analysis performed, including modeling techniques, patient populations, outcome measures, cost estimates and any underlying assumptions.

    The guidance said terms of value-based contracts between manufacturers and payers lie outside the scope of FDA regulation. It said FDA "does not intend to object" to sharing certain information with payers prior to products' approval, including factual and non-misleading statements about product information, indications sought, estimated approval timelines, and clinical or preclinical results.

    In separate draft guidance released Tuesday, FDA recommended ways to convey truthful, non-misleading information that is "consistent with" a product's label, but not included in the label (see BioCentury Extra, Jan. 17).

    In Wednesday's memorandum, FDA outlined its concerns regarding promotion of unapproved uses of approved drugs. The agency said it must balance public health needs with First Amendment protections, and described potential approaches to doing so. The agency asked stakeholders to comment on the memorandum's proposals, as well as both draft guidances.

    FDA held a hearing Nov. 9-10, 2016, on off-label communications. A think tank headed by former FDA Commissioner Mark McClellan, the Duke-Margolis Center for Health Policy, issued a white paper on the matter in February 2016 (see BioCentury, Feb. 29, 2016).

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