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BioCentury Extra
As published Wednesday, October 29, 2014 7:26 PM PST

  • Sanofi ouster opens can of worms

    Sanofi (Euronext:SAN; NYSE:SNY) shares touched a 52-week low of $44.50 in New York on Wednesday before its ADSs closed down $2.85 (6%) to $45.22, on the news that Christopher Viehbacher had been removed as CEO, a move that leaves several loose ends affecting the industry.

    The pharma issued a brief statement early Wednesday morning, saying its board had met at 8.a.m. and "decided unanimously" to remove Viehbacher as CEO, after which he resigned as a director. On Monday, the company had issued a terse statement in response to media reports the board intended to discuss the ouster at a separate meeting on Monday, saying "there is no agenda item regarding the succession of Chris Viehbacher" when the board met to review the company's 3Q14 results.

    Sanofi named Chairman Serge Weinberg as interim CEO. The pharma said Viehbacher also has been removed as chairman of Sanofi's Genzyme Corp. unit, which is headed by President and CEO David Meeker.

    While Sanofi is restructuring its leadership, its move leaves other open questions of interest to the pharma space.

    Viehbacher, a former chairman of PhRMA, still was chair of the trade group's FDA and Biomedical Research Committee and had been involved in the industry's continuous engagement process with the agency, initiated after the PDUFA V agreement, and has been involved in the preparations for the next round of user fee negotiations that will lead to PDUFA VI.

    Both Sanofi and PhRMA declined to comment on Viehbacher's status at PhRMA, but he has been removed from the list of board members on the association's website.

    Sanofi did say that Elias Zerhouni, its global president of R&D, remains head of PhRMA's Biomedical Advisory Council (BMAC).

    Viehbacher was elected president of the European Federation of Pharmaceutical Industries and Associations in June 2013 for a two-year term. EFPIA said was unable to comment immediately on Viehbacher's future status as president.

    On Euronext, Sanofi fell EUR 3.38 (4.5%) to EUR 71.15.

    Shares of partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) fell $10.19 to $387.70. The stock has fallen $19.46 (4.8%) from a recent high of $407.16 since Monday, when French newspaper Les Echos reported that Viehbacher had sent a letter to the board calling for resolution of his status as chief executive. According to the letter published online by the newspaper, the author writes that "my sudden departure would concern our partners," which "can easily be verified by a discussion with Len Schleifer, CEO of Regeneron."

    Sanofi and Regeneron are racing with Amgen Inc. (NASDAQ:AMGN) to bring competing cholesterol lowering drugs to market. The partners plan to submit a BLA to FDA before year end for alirocumab, a human mAb targeting proprotein convertase subtilisin/kexin type 9 to treat hypercholesterolemia. Amgen submitted a BLA in September for its anti-PCSK9 compound evolocumab to treat high cholesterol.

    Regeneron has lost $1.9 billion in market cap since Monday to $38.4 billion. The biotech declined to comment on Viehbacher's departure, saying the biotech is "looking forward to working with future leadership."

  • FDA approves Pfizer's meningitis B vaccine

    FDA granted accelerated approval for Trumenba from Pfizer Inc. (NYSE:PFE) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25. The bivalent meningococcal B vaccine targeting LP2086 (factor H binding protein) had breakthrough therapy and Priority Review designations, and was approved ahead of its Feb. 14 PDUFA date.

    Pfizer said it will complete ongoing studies of Trumenba to protect against diverse serogroup B strains. Spokesperson Sally Beatty said Pfizer will make Trumenba available "within weeks," and has not yet priced the vaccine.

  • Xencor revises XmAb5871 deal with Amgen

    Xencor Inc. (NASDAQ:XNCR) renegotiated its deal with Amgen Inc. (NASDAQ:AMGN) related to autoimmune candidate XmAb5871. Xencor terminated the companies' original deal in which the bellwether had an option to license exclusive, worldwide rights to XmAb5871 upon completion of a Phase II trial to treat rheumatoid arthritis (RA).

    Xencor said it wants to develop the antibody for diseases with higher unmet need. Thus, Xencor plans to instead develop XmAb5871 for other autoimmune diseases including the rare disorder IgG4-related disease. Xencor granted Amgen the right of first negotiation to license XmAb5871.

    Amgen's newly acquired right of first negotiation to license the humanized mAb targeting CD19 and Fc gamma receptor IIb (CD32B; FCGR2B) will expire upon the start of a Phase III trial, a change of control of Xencor or in October 2019, whichever comes first.

    Xencor had been eligible to receive up to $500 million from the original deal, including an upfront payment, an option-exercise fee and milestones, plus tiered royalties. New financial terms were not disclosed.

    Xencor lost $0.11 to $10.49 on Wednesday. The renegotiated deal was announced after market trading Tuesday.

  • Regulus raises $75M in follow-on

    Regulus Therapeutics Inc. (NASDAQ:RGLS) wasted little time cashing in on a recent stock surge, as the microRNA company raised $75 million through the sale of 4.4 million shares at $17 in a follow-on underwritten by Deutsche Bank; BMO; Needham; Wedbush; and FBR.

    Regulus proposed the offering after market on Monday, when its share price was $18.47. Regulus surged $6.98 (103%) to $13.75 on Oct. 22 after interim Phase I data showed the company's RG-101 led to significant and sustained viral reductions in HCV patients.

    The company plans to submit an IND in 1Q15 and begin a Phase II trial combining RG-101 with a direct-acting antiviral agent to treat HCV in 2Q15.

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS) also capitalized on Regulus' uptick. Isis sold about 882,000 Regulus shares in the follow-on, raising $15 million.

    Regulus was up $0.47 to $18.08 on Wednesday. Isis was down $1.42 to $45.01.

  • Vanda raises $58M in follow-on

    Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) raised $58 million through the sale of 5 million shares at $11.60 in a follow-on underwritten by Jefferies; Piper Jaffray; JMP Securities; and Canaccord. The neurology company proposed the offering on Tuesday, when its share price was $12.03.

    Vanda said it would use the proceeds to commercialize Hetlioz tasimelteon in the U.S. FDA approved the melatonin MT1 and MT2 receptor agonist in January to treat non-24-hour sleep wake disorder. The drug is under EMA review, with a decision expected in 3Q15.

    Vanda reported $56.1 million in cash on Sept. 30. Vanda closed down $0.06 to $11.97 on Wednesday.

  • Chimerix planning $105M follow-on

    Chimerix Inc. (NASDAQ:CMRX) said it plans to raise about $105 million in a follow-on underwritten by Morgan Stanley; JP Morgan; Cowen; Piper Jaffray; and Stifel, Nicolaus.

    Chimerix's brincidofovir is in Phase III trials to prevent cytomegalovirus (CMV) infection in adults undergoing hematopoietic stem cell transplant (HSCT). It also is in Phase III testing to treat adenovirus infection and Phase II testing to treat Ebola virus infection.

    The follow-on would be the company's second this year. In May, Chimerix raised $119.4 million through the sale of 8.4 million shares at $14.22.

    The new financing was proposed after market close Wednesday. Chimerix closed down $1.65 to $29.79 on the day.

  • Synergy raises $175M in note deal

    Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) raised $175 million through the sale of senior unsecured convertible notes. The notes bear 7.5% interest, mature in 2019 and initially convert at $3.11.

    Synergy's lead compound is plecanatide, a guanylate cyclase C (GCC; GUCY2C) agonist that is in two Phase III trials for chronic idiopathic constipation.

    Synergy was up $0.31 (10%) to $3.42 on Wednesday.

  • Rep. McCaul outlines compassionate access bill

    Rep. Michael McCaul (R-Texas) plans to introduce compassionate access legislation that would impose new requirements on drug developers and establish rights for patients. McCaul summarized the legislation and his reasons for introducing it in a white paper submitted to the House Energy & Commerce Committee's 21st Century Cures initiative.

    McCaul's bill would require companies applying for accelerated approval, breakthrough, Fast Track or Priority Review designations to "develop and make publicly available their expanded access policy for such treatments." The white paper suggests that companies post information about access to investigational therapies on their websites, including a single point of contact for requests, a description of the application procedure, minimum eligibility requirements, and an expected response time.

    The bill also seeks to require drug companies to inform patients when access to an investigational therapy is denied, and explain the reasons.

    Furthermore, the bill would mandate that companies disclose all requests for compassionate access to FDA. It would also establish a stakeholder taskforce to recommend additional reforms to the system.

  • EMA could allow extrapolation for biosimilars

    EMA's final guidance outlining general principles for developing biosimilars in the EU suggests that regulators may allow extrapolation of evidence of biosimilarity from one indication to others. The detail is among a handful of changes from draft guidance issued in May 2013 (see BioCentury Extra, May 2, 2013).

    The final guidance says, "If biosimilarity has been demonstrated in one indication, extrapolation to other indications of the reference product could be acceptable with appropriate scientific justification."

    The guidance, which takes effect April 30 and replaces 2005 guidance, also clarifies that biosimilar sponsors need not repeat demonstration of biosimilarity against reference products, if there has been a change in the manufacturing process.

    In addition, the final guidance added language stipulating that the active substance of a biosimilar must be similar in molecular and biological terms to the active substance of the reference product. Moreover, the guidance requires justification for any deviations from the reference product in strength and pharmaceutical form, with additional data to support the deviations if needed.

    FDA is still assessing the issue of extrapolation of indications for biosimilars. Its decisions about extrapolation will be based on knowledge of the mechanism of action of the reference product, as well as the degree of similarity between the reference and biosimilar products, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told BioCentury This Week television this month (see BioCentury This Week, Oct. 12, 2014).

    Amgen Inc. (NASDAQ:AMGN) said this month that it will seek to use clinical data for its ABP 501, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV), in two indications and extrapolate the findings to all of the indications on Humira's label. Humira is a human mAb against tumor necrosis factor (TNF) alpha (see BioCentury Extra, Oct. 8, 2014).

  • Senators seek to incentivize Ebola research

    Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) plan to introduce a bill that would add Ebola to the list of eligible diseases under FDA's Priority Review voucher program for tropical diseases.

    Upon FDA approval of a drug that targets a tropical disease on the list, a company can receive a voucher that can be used to obtain Priority Review for a different product in its pipeline. The voucher also can be sold.

    It remains unclear whether the bill would dramatically incentivize Ebola research. Only three Priority Review vouchers have been awarded to companies with approved tropical disease drugs since the program's inception in 2007. Also, FDA must be notified a year in advance of a company's intent to use a voucher.

    Neither Harkin's nor Alexander's offices responded to questions about whether the legislation would seek to change the requirements for using a voucher.

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