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BioCentury Extra
As published Friday, January 30, 2015 6:08 PM PST

  • Spark catches fire in first trading day

    Gene therapy developer Spark Therapeutics Inc. (NASDAQ:ONCE) gained $27 (117%) to $50 on Friday, its first day of trading after raising $161 million in an IPO on NASDAQ through the sale of 7 million shares at $23. The IPO price valued Spark at $540.3 million; it ended the day with a market cap of $1.2 billion.

    On Wednesday, Spark said it planned to sell 6.5 million shares at $19-$21. At $20, the company would have raised $130 million and been valued at $459.8 million. JPMorgan; Credit Suisse; Cowen; and Sanford C. Bernstein are underwriters.

    Spark expects data next half from a Phase III trial of lead program SPK-RPE65 (AAV2-hRPE65v2) to treat inherited retinal dystrophies, including Leber's congenital amaurosis (LCA). The adeno-associated viral (AAV) serotype 2 vector encoding the retinal pigment epithelium-specific protein 65kDa (RPE65) gene has Orphan Drug designation in the U.S. and EU for LCA, and breakthrough therapy designation to treat nyctalopia, or night blinding, in patients with LCA.

    Spark's largest shareholder, The Children's Hospital of Philadelphia, holds 37.5% after the offering, worth $440.4 million at Friday's close. CHOP was the sole investor in Spark's $10 million series A round, and invested $22.5 million of its $72.7 million series B round.

    Sofinnova Venture Partners holds 8.1%, while affiliates of hedge fund Baker Bros. Advisors have 5.4% (see BioCentury Extra, Dec. 31, 2014).

  • Biogen up as earnings top estimates

    Biogen Idec Inc. (NASDAQ:BIIB) jumped $35.58 (10%) to $388.83 on Friday, reaching an all-time high after its 4Q14 earnings beat the Street.

    The company's 4Q14 non-GAAP diluted EPS was $4.09, up 75% from $2.34 in the previous year's quarter and beat the Street estimate by $0.31. Biogen issued guidance of $16.60-$17 for 2015 non-GAAP diluted EPS on revenue growth of 14-16%, above analysts' estimates of $16.37.

    Biogen reported full year 2014 revenues of $9.7 billion, a 40% increase from $6.9 billion the year prior. Its 4Q14 revenues were $2.6 billion, up 34% from $2 billion in 4Q13.

    Sales of MS drug Tecfidera dimethyl fumarate were $916 million in 4Q14 and $2.9 billion for the year, compared to $397.6 million in 4Q13 and $876.1 million in 2013. The company anticipates continued sales growth of the drug; on Friday's earnings call, Tony Kingsley, EVP of global commercial operations, said Tecfidera "is on track to become the most prescribed therapy for MS worldwide."

  • AbbVie forecasts $3B run rate for Viekira Pak

    On its 4Q14 earnings call on Friday, AbbVie Inc. (NYSE:ABBV) forecast that it would achieve a global annualized sales run rate of $3 billion for HCV drug regimen Viekira Pak paritaprevir/ritonavir/ombitasvir/dasabuvir by YE15.

    Approved Dec. 19, the drug has sparked a price war for exclusive formulary status with competitor Gilead Sciences Inc. (NASDAQ:GILD) and its HCV drugs Harvoni ledipasvir/sofosbuvir and Sovaldi sofosbuvir.

    AbbVie President and CEO Richard Gonzalez told investors that based on payer decisions to back either Gilead's or AbbVie's drugs, "over half of the managed care lives in the U.S. are now under contract." He said based on the process to date, "we estimate that more than 40% of covered lives will have access to Viekira, including both the exclusive and parity positions we have secured," with 20% of the lives covered by Viekira exclusively.

    In addition to the biotech's disclosed deal with pharmacy benefit manager Express Scripts Holding Co. (NASDAQ:ESRX), Gonzalez said AbbVie had reached exclusive deals "with a number of different more regional" payers and PBMs, including Blue Shield of California.

    Blue Shield of California told BioCentury the selection of Viekira would apply to its commercial and Covered California plans. The payer does not manage any Medicaid plans.

    AbbVie said 1,100 Viekira prescriptions have been written through Jan. 16.

    The company forecast 2015 non-GAAP EPS of $4.25-$4.45 and reported non-GAAP 4Q14 EPS of $0.89, beating consensus estimates by $0.03 and up 9% from $0.82 in 4Q13.

    AbbVie lost $2.77 to $60.35 on Friday.

  • ImmunoGen gains on 4Q14 earnings

    ImmunoGen Inc. (NASDAQ:IMGN) rose $1.43 (23%) to $7.63 on Friday after reporting 4Q14 earnings that beat analysts' estimates. The company has yet to regain ground lost in mid-December after Roche (SIX:ROG; OTCQX:RHHBY) reported disappointing data from a Phase III trial of breast cancer drug Kadcyla ado-trastuzumab emtansine, an antibody-drug conjugate of a humanized mAb against HER2 linked to ImmunoGen's DM1 cytotoxic agent (see BioCentury, Dec. 22, 2014).

    ImmunoGen reported 4Q14 revenues of $48.3 million, up from $30.1 million in 4Q13 and above the Street's estimate of $37.1 million. Most came from licensing fees and milestone payments, including $41.4 million from partners Novartis AG (NYSE:NVS; SIX:NOVN) and Eli Lilly and Co. (NYSE:LLY). In 4Q13, the company received $25.7 million from license fees and milestones.

    The company's quarterly revenue also included $4.6 million in royalties from Roche on Kadcyla sales, up from $2.3 million in 4Q13.

    Net earnings for the quarter were $0.16 per share, beating consensus estimates of a loss of $0.05 per share. The company's 2015 revenue guidance was $100-$105 million, unchanged from the previous quarter.

    ImmunoGen lost $4.74 to $6.11 (44%) on Dec. 19 after Roche's announcement.

  • Valeant makes $296M bid for Provenge

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) made a $296 million cash bid to acquire selected assets of bankrupt Dendreon Corp. (Pink:DNDNQ), including global rights to prostate cancer vaccine Provenge sipuleucel-T.

    The agreement makes Valeant the "stalking horse" bidder for those assets in Dendreon's Chapter 11 bankruptcy auction, scheduled for Feb. 12. Valeant is entitled to a breakup fee plus reimbursement of expenses if it is outbid. Dendreon extended the bidding deadline to Feb. 10.

    Dendreon spokesperson Eric Kuo said the company will soon issue an SEC filing with the full terms of the agreement, including the assets involved.

    Dendreon filed for bankruptcy in November after disclosing in August that it might not be able to repay or refinance its $620 million of unsecured notes due Jan. 15, 2016. Bidding was to start at $275 million (see BioCentury Extra, Nov. 10, 2014).

    Sales of Provenge, the first cancer vaccine approved in the U.S., were $303.8 million in 2014. Provenge comprises autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine.

    Valeant said it was seeking an "economic way" to enter the oncology market.

    Valeant lost $1.54 to $159.97 in New York and C$0.46 to C$203.17 in Toronto on Friday.

  • FDA approves Vyvanse for binge-eating disorder

    FDA approved an sNDA under Priority Review for Vyvanse lisdexamfetamine dimesylate (S-877489) from Shire plc (LSE:SHP; NASDAQ:SHPG) to treat binge-eating disorder in adults. The agency said Vyvanse is the only FDA-approved treatment for this indication.

    Vyvanse, Shire's top-selling drug, is approved to treat ADHD in the U.S., Canada and Australia. Sales of the prodrug of amphetamine were $1.1 billion over the nine months ended Sept. 30, 2014.

    Shire dipped $2.91 to $219.26 on NASDAQ and lost 44p to 4,854p in London on Friday. FDA announced the approval after market close.

  • Tracon takes haircut, raises $36M in IPO

    Oncology company Tracon Pharmaceuticals Inc. (NASDAQ:TCON) lost $0.60 to $9.40 in its first day of trading on Friday after raising $36 million in an IPO on NASDAQ through the sale of 3.6 million shares at $10. The price valued Tracon at $120.9 million, including shares purchased by New Enterprise Associates in a concurrent $5 million private placement at the IPO price.

    Last week, Tracon said it planned to sell 3.6 million shares at $12-$14. At $13, Tracon would have raised $46.8 million and been valued at $155.7 million. Wells Fargo; Stifel; Needham; and Oppenheimer are underwriters.

    Tracon expects data in late 2015 to mid-2016 from four Phase II combination trials of lead program TRC105 to treat various cancers, including advanced soft tissue sarcoma, metastatic or advanced renal cell carcinoma (RCC), glioblastoma multiforme (GBM) and hepatocellular carcinoma (HCC). TRC105 is an antibody to endoglin, a protein essential for angiogenesis that is overexpressed on endothelial cells.

  • Venture tracks

    Canadian venture firm CTI Life Sciences hired Janelle Anderson as managing partner and promoted Shermaine Tilley to managing partner from partner. Anderson was a managing director at MRL Venture Fund, the corporate venture arm of Merck & Co. Inc. (NYSE:MRK). Tilley joined CTI in 2006 and is a director at Xagenic Inc. (Toronto, Ontario) and Zymeworks Inc. (Vancouver, B.C.).

  • Obama seeks $215M for Precision Medicine Initiative

    President Obama detailed plans on Friday for the Precision Medicine Initiative first announced in last week's State of the Union address. The FY16 budget request, due for release next Monday, will include $215 million to launch the initiative (see BioCentury Extra, Jan. 21).

    The request will include $130 million for NIH to recruit a cohort of 1 million research volunteers and study their patient data. NIH's National Cancer Institute (NCI) would be allocated an additional $70 million to identify genomic drivers of cancer and seek new treatments. FDA would receive $10 million for database development, including developing a new approach for evaluating next-generation sequencing technologies. The Office of the National Coordinator for Health Information Technology (ONC) would receive $5 million to develop standards for secure data exchange while guarding privacy. The Obama administration also aims to promote public-private partnerships to support the initiative.

    In attendance was Sen. Lamar Alexander (R-Tenn.), chairman of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, who released a report yesterday with Sen. Richard Burr (R-N.C.) to identify opportunities for reform at NIH and FDA (see BioCentury Extra, Jan. 29).

    Industry executives were also present, including David Altshuler, CSO of Vertex Pharmaceuticals Inc. (NASDAQ:VRTX); Steven Kafka, COO of Foundation Medicine Inc. (NASDAQ:FMI); and Tony Coles, CEO of Yumanity Therapeutics LLC (Cambridge, Mass.).

  • CDER names Shreeve communications director

    FDA's Center for Drug Evaluation and Research hired Christine Shreeve as director of its Office of Communications (OCOMM), effective March 8.

    Shreeve has been director of social marketing at public relations firm Ketchum Inc. since 2006. She was previously SVP at Ogilvy Public Relations.

    Kimberly Rawlings, who has been serving as OCOMM's acting director, will return to her role as deputy director.

  • Market Entry Strategy and Planning with Campbell Alliance

    Find a commercialization partner, or go it alone? This decision involves not only strategic questions regarding a company's identity and core competencies, but also multiple value drivers that are easy to overlook. This article examines how a value-based approach can help companies position themselves to ensure their business plans contribute to a product's success and an improved return on investment. Download your copy now!

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