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BioCentury Extra
As published Wednesday, October 26, 2016 6:47 PM PST

  • Biogen reports Tecfidera growth, ends S1P program

    In its 3Q16 earnings report, Biogen Inc. (NASDAQ:BIIB) said sales of multiple sclerosis drug Tecfidera dimethyl fumarate grew 10% compared to 3Q15. The company also said it discontinued development of autoimmune candidate amiselimod (MT-1303), a sphingosine 1-phosphate (S1P) receptor functional agonist whose rights Biogen had obtained from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508).

    Tecfidera sales were $1.03 billion in 3Q16, compared with $937 million in 3Q15, and up 5% sequentially from 2Q16. Biogen estimated that the latest sales figure included a $40-$50 million benefit compared with the prior quarter due to U.S. inventory buildup. In a Wednesday regulatory filing, Biogen attributed the sales growth primarily to price increases. A slowdown in Tecfidera's sales growth was among several factors that led to a long slump in Biogen's stock price during 2015 and 1H16 (see BioCentury, July 25).

    Biogen discontinued amiselimod based on a reprioritization of strategic objectives, EVP and Head of R&D Michael Ehlers said on a conference call Wednesday. Since licensing the compound, Biogen evaluated it for various autoimmune indications, "with a particular interest in inflammatory bowel disease," Ehlers said. He said changes in the IBD treatment landscape factored into the company's decision. In a September 2015 deal, Biogen paid $60 million up front to obtain worldwide, ex-Asian rights to amiselimod from Mitsubishi. The deal included $484 million in milestones. Biogen did not respond to inquiries about whether any milestones were paid (see BioCentury Extra, Sept. 9, 2015).

    Biogen announced $31 million in revenue from sales of biosimilars during 3Q16. This year, the company launched autoimmune drugs Benepali, a biosimilar of Enbrel etanercept; and Flixabi, a biosimilar of Remicade infliximab in Europe. Amgen Inc. (NASDAQ:AMGN) markets Enbrel, while Johnson & Johnson (NYSE:JNJ) markets Remicade.

    CEO George Scangos said the company's board is still searching for his replacement. Biogen said in July that Scangos would step down after the company identifies his successor (see BioCentury Extra, July 21).

    For 3Q16 overall, Biogen reported adjusted EPS of $5.19 on revenues of $3 billion, topping consensus estimates of $4.97 per share on revenues of $2.9 billion. Biogen shares rose $10.46 to $296.46 on Wednesday.

  • Humana covering Sarepta's Exondys 51

    In a policy statement, Humana Inc. (NYSE:HUM) said it will cover Duchenne muscular dystrophy treatment Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT). The coverage is restricted to ambulatory patients who have a confirmed mutation of the DMD gene amenable to exon 51 skipping.

    Last month, FDA granted accelerated approval to Exondys 51 to treat DMD amenable to exon 51 skipping. Sarepta priced the drug at a net annual cost of $300,000 for a 25 kg boy. Exondys 51 is a phosphorodiamidate morpholino (PMO) that induces skipping of exon 51 dystrophin mRNA (see BioCentury, Sept. 26).

    Cigna Corp. (NYSE:CI) and UnitedHealth Group Inc. (NYSE:UNH) have said they will cover Exondys 51, while Anthem Inc. (NYSE:ANTM) said it will not cover the treatment (see BioCentury Extra, Oct. 7).

    Sarepta slipped $1.83 to $44.50 on Wednesday.

  • Lynparza PFS tops expectations in SOLO-2

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said Lynparza olaparib showed a significant progression-free survival benefit vs. placebo in the Phase III SOLO-2 trial to treat BRCA-mutated metastatic ovarian cancer. The pharma said the median PFS in SOLO-2's Lynparza arm "substantially exceeded" the benefit previously seen in Phase II Study 19.

    Data from Study 19 published in 2014 in The Lancet showed that Lynparza led to a median PFS of 11.2 months vs. 4.3 months for placebo (HR=0.18, p<0.0001) among patients with a germline or tumor BRCA mutation. That trial evaluated the PARP inhibitor as maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer, and was not restricted to patients with BRCA mutations.

    SOLO-2 enrolled 295 ovarian cancer patients with germline BRCA mutations who had received at least two prior lines of platinum-based chemotherapy. AstraZeneca did not release specific survival data, and plans to present them at a future medical meeting. The pharma did not respond to inquiries about its regulatory plans.

    Lynparza has accelerated approval from FDA as fourth-line monotherapy to treat germline BRCA-mutated advanced ovarian cancer. It has EU approval in the maintenance setting for relapsed BRCA-mutant patients in response to chemotherapy.

    In June, Tesaro Inc. (NASDAQ:TSRO) said data from its Phase III NOVA trial showed that maintenance treatment with its PARP inhibitor niraparib (MK-4827) led to a median PFS of 21 months vs. 5.5 months for placebo (HR=0.27, p<0.00001) among BRCA-mutant, platinum-sensitive recurrent ovarian cancer patients. Spokesperson Jennifer Davis said Tesaro expects to complete a rolling submission of an NDA this quarter for niraparib in the maintenance setting (see BioCentury, July 11).

    Clovis Oncology Inc. (NASDAQ:CLVS) expects data in 4Q17 from the Phase III ARIEL3 trial of PARP inhibitor rucaparib (CO-338) as maintenance therapy in BRCA-mutant ovarian cancer patients with homologous recombination deficiencies.

    Tesaro dipped $3.09 to $119.06 on Wednesday. Clovis added $0.22 to $30.62.

  • Genomics Medicine Ireland raises $40M series A

    Genomics Medicine Ireland Ltd. (Dublin, Ireland) raised $40 million in a series A round. Arch Venture Partners, Polaris Partners, Ireland Strategic Investment Fund and the GV venture arm of Alphabet Inc. (NASDAQ:GOOG) participated equally in the round.

    Genomics Medicine intends to conduct population-scale genome studies in Ireland and build a disease-specific database in order to better understand the role of genetics and lifestyle factors in diseases, including rare conditions. The start-up aims to seek partners to develop better diagnostics and targeted therapies.

    The start-up's business plan remains "broad at the moment," according to Polaris' Terry McGuire. He said the company has a "fundamental belief that if we can create a tool to interrogate and understand all the genetic insights in Ireland's very broad population, then we'll have a lot of different ways to work with partners and create value for shareholders."

    Genomics Medicine's platform is based on the work of the deCode genetics ehf subsidiary of Amgen Inc. (NASDAQ:AMGN), one of the newco's partners. It has also has an infrastructure partnership with contract genomics organization WuXi NextCODE, a subsidiary of New WuXi Life Science Ltd. (Shanghai, China).

    Genomics Medicine plans to establish a genomic R&D center in Dublin and create 150 jobs over the next three years.

  • Ra shares unchanged after $91.6M IPO

    Peptide therapeutics company Ra Pharmaceuticals Inc. (NASDAQ:RARX) closed unchanged Wednesday after it raised $91.6 million through the sale of 7 million shares at $13 in an IPO underwritten by Credit Suisse, Jefferies, BMO Capital Markets and SunTrust Robinson Humphrey. The price valued Ra at $279.4 million.

    Last week, Ra said it hoped to sell 5.8 million shares at $12-$14. At the $13 midpoint, it would have raised $75.4 million and been valued at $263.1 million. The company filed last month to raise up to $86.3 million.

    Ra plans to begin Phase II testing in 1Q17 of lead candidate RA101495 to treat paroxysmal nocturnal hemoglobinuria (PNH), and expects data in 2H17. The compound is a peptide inhibitor of complement 5 (C5).

  • Collegium raises $80M follow-on

    Abuse-deterrent analgesics company Collegium Pharmaceutical Inc. (NASDAQ:COLL) raised $80 million through the sale of 5 million shares at $16 in a follow-on underwritten by Jefferies, Piper Jaffray, William Blair, Needham and Janney Montgomery Scott. The price represents a 5% discount to Collegium's $16.87 closing price on Tuesday, when the company announced the offering after market hours. Collegium sank $1.25 to $15.62 on Wednesday.

    In June, Collegium launched Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is extended-release oral oxycodone formulated with DETERx tamper resistance technology.

  • Fund+ closes EUR 125M fund

    Fund+ closed its Belgian Life Sciences fund at EUR 125 million ($136.1 million), exceeding its EUR 100 million ($108.9 million) target. Investors included SFPI-FPIM, SRIW, Meusinvest, Spinventure and Sambrinvest, as well as private investors and family offices. Fund+ plans to invest in 12-15 drug development, medical device and in vitro diagnostics companies.

    The new fund has already invested in women's health company Ogeda S.A. (Brussels, Belgium); cell therapy companies Promethera Biosciences S.A. (Mont-Saint-Guibert, Belgium), MaSTherCell S.A. (Gosselies, Belgium) and Novadip Biosciences S.A. (Louvain La Neuve, Belgium); and cancer companies iTeos Therapeutics S.A. (Gosselies, Belgium) and eTheRNA N.V. (Brussels, Belgium).

  • Adapt or Fail: Succeeding in the Age of the Organized Customer

    In today's value-focused environment, the relationships that pharmaceutical companies have with organized customers are shifting rapidly. In this white paper, inVentiv Health Consulting takes a look at challenges companies continue to face in their approach, and strategies to consider for maximizing opportunities for fostering deeper and more mutually valuable customer relationships. Download now.

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