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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Sovaldi sales hit $3.5 billion in 2Q14

Gilead Sciences Inc. (NASDAQ:GILD) reported 2Q14 financial results that beat the Street, including $3.5 billion in sales of HCV drug Sovaldi sofosbuvir. The Street was expecting $2.5-$2.6 billion in Sovaldi sales in the quarter. About $3 billion of Sovaldi's 2Q14 sales were in the U.S., where 65% of its usage is in patients with HCV genotype 1 infection. According to Gilead, Sovaldi has been prescribed for more than 80,000 patients in the U.S. and Europe through June 30 since its launch; the company launched Sovaldi in the U.S. in December and in Europe earlier this year. more >>

   FINANCIAL NEWS

Biogen Idec jumps on 2Q14 results

Biogen Idec Inc. (NASDAQ:BIIB) gained $33.93 (11%) to $337.60 on Wednesday after reporting 2Q14 financial results that beat consensus EPS and sales estimates. The move translates to a gain of $8 billion in market cap for a closing valuation of $79.7 billion. Non-GAAP diluted EPS grew 52% to $3.49 from 2Q13 and beat by $0.66 the Street's $2.83 estimate. Revenues in the quarter rose 40% to $2.4 billion from $1.7 billion in 2Q13 and beat the Street's estimate of $2.2 billion. more >>

GSK reports 2Q14 results, lowers 2014 guidance

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reported 2Q14 financial results on Wednesday that missed consensus EPS and sales estimates; the pharma also lowered its 2014 guidance. The pharma's 2Q14 core EPS dropped 12% to 19.1p and missed the Street's 21.35p estimate, while sales in the quarter were off 4% to L5.6 billion ($9.5 billion), missing the Street's L5.8 billion ($9.9 billion) estimate. Pharmaceutical sales were down 6% to L3.8 billion ($6.4 billion) compared to 2Q13. more >>

Sofinnova raises $500 million for ninth fund

Sofinnova Ventures raised $500 million for Sofinnova Venture Partners IX, its ninth fund and second life sciences-only fund. The firm was targeting $425 million for the fund, which was oversubscribed. Sofinnova plans to invest the fund in 20-22 therapeutics companies primarily in the U.S. but also in Europe. The firm said it will invest the fund in companies developing specialty pharmaceuticals and Orphan disease products. more >>

Puma soars on neratinib news

Puma Biotechnology Inc. (NYSE:PBYI) jumped $174.40 (295%) to $233.43 on Wednesday after the company reported top-line data for oral neratinib (PB272) as adjuvant treatment of HER2-positive breast cancer late Tuesday and separately said it will be responsible for more trial costs for the product but will owe lower royalty rates to partner Pfizer Inc. (NYSE:PFE). Puma's Wednesday move translates to a gain in market cap of $5.3 billion for a closing valuation of $7 billion. With the move, Puma is also now above its close of $139.92 on Jan. 21, before the company slid after reporting detailed efficacy and safety data for the oral inhibitor of HER1, HER2 and HER4 kinases from the adaptive Phase II I-SPY 2 trial evaluating neoadjuvant breast cancer therapies (see BioCentury Extra, July 22). more >>

Remiges raises $70 million for $150 million fund

Remiges Ventures has raised $70 million of the targeted $150 million in its Remiges BioPharma Fund L.P., according to an SEC filing. The firm will invest in early stage companies in the U.S. and Europe that are developing therapeutics "with a definable commercial opportunity in the U.S. market." Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) and Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) are each investing $30 million in the fund. Remiges, which could not be reached for comment, has offices in Cambridge, Mass., and Tokyo. more >>

La Jolla raises $50.4 million in follow-on

La Jolla Pharmaceutical Co. (NASDAQ:LJPC) raised $50.4 million through the sale of 4.8 million shares at $10.50 in a follow-on underwritten by Jefferies; Chardan Capital Markets; H.C. Wainwright; LifeSci Capital; and Noble Financial Group. La Jolla proposed the follow-on late Tuesday, when its share price was $10.95. more >>

KineMed pulls IPO

Biomarker discovery company KineMed Inc. (Emeryville, Calif.) withdrew its IPO on NASDAQ, citing "market conditions." The company declined to comment on future financing plans. Last month, KineMed amended its IPO to sell 4.5 million shares at $6.50-$7.50. At the $7 midpoint, the company would have raised $31.5 million and been valued at $113.8 million. In January, the company filed to raise up to $50.9 million, with H.C. Wainwright; MKM Dillon; and Dawson James Securities as underwriters. KineMed replaced the underwriters with Feltl; MLV; and Laidlaw in June. In 1Q14, the company reported $1.4 million in revenues and had a three-month operating loss of $1.7 million. As of March 31, KineMed had $7.3 million in cash. more >>

   COMPANY NEWS

FDA approves Gilead's idelalisib

FDA approved Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) on Wednesday for three blood cancers. The agency granted full approval to Zydelig in combination with rituximab to treat relapsed chronic lymphocytic leukemia (CLL), for which the compound has breakthrough therapy designation. FDA granted accelerated approval to the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta as monotherapy to treat relapsed follicular B cell non-Hodgkin's lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) -- both types of indolent NHL. The accelerated approvals are based on the single-arm Phase II Study 101-09, where Zydelig led to an overall response rate (ORR) of 54% in 72 FL patients and 58% in 26 SLL patients (see BioCentury Extra, Dec. 9, 2013). more >>

FDA approves Purdue's abuse-deterrent oxycodone/naloxone

FDA approved an NDA for Targiniq ER oxycodone/naloxone from Purdue Pharma L.P. (Stamford, Conn.) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is an abuse-deterrent, extended-release/long-acting combination of oxycodone and naloxone. Purdue declined to disclose launch plans, including pricing. more >>

ArmaGen licenses AGT-182 to Shire

ArmaGen Technologies Inc. (Calabasas, Calif.) granted Shire plc (LSE:SHP; NASDAQ:SHPG) exclusive, worldwide rights to develop and commercialize AGT-182, which is in development to treat mucopolysaccharidosis type II (MPS-II, Hunter's syndrome). ArmaGen will receive $15 million up front in cash and equity. The company is also eligible for up to $210 million in an additional equity investment, R&D funding and milestones, plus up to double-digit royalties. ArmaGen will conduct a Phase I/II trial of AGT-182, after which Shire will be responsible for further development and commercialization. ArmaGen expects to start the Phase I/II trial by year end. more >>

FDA approves Eagle's Ryanodex for malignant hyperthermia

FDA approved an NDA from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) for Ryanodex dantrolene to treat malignant hyperthermia. The company said it plans to launch the drug next month at a wholesale acquisition cost of $2,300 for a 250 mg vial. Eagle told BioCentury that one vial of Ryanodex "is sufficient to provide a loading dose for patients up to 100 kg. The average total dosage required to treat a patient during an MH episode typically requires one-to-three vials, depending on the patient's weight and condition severity." more >>

   CLINICAL NEWS

UCB's brivaracetam meets in Phase III epilepsy trial

UCB Group (Euronext:UCB) said adjunctive treatment with once-daily brivaracetam for 12 weeks met the FDA-defined and EMA-defined primary endpoints vs. placebo in the Phase III N01358 trial to treat partial-onset seizures in epilepsy patients. The FDA-defined endpoint was percent reduction in partial-onset seizure frequency from baseline to day 28, and the EMA-defined endpoint was a 50% responder rate for partial-onset seizure frequency at day 28. The double-blind, international trial enrolled 768 patients with partial-onset seizures not fully controlled despite treatment with one to two concomitant antiepileptic drugs. more >>

Inovio's VGX-3100 meets in Phase II for cervical dysplasia

Inovio Pharmaceuticals Inc. (NYSE-M:INO) gained $1.96 (18%) to $13.10 on Wednesday after reporting that intramuscular VGX-3100 followed by electroporation with Inovio's Cellectra device met the primary endpoint vs. placebo in a Phase II trial to treat cervical intraepithelial neoplasia (CIN) associated with HPV types 16 or 18. VGX-3100 followed by electroporation at weeks 0, 4 and 12 led to a greater proportion of patients with histopathological regression of cervical dysplasia to CIN grade 1 or no disease at week 36 vs. placebo (49.5% vs. 30.6%, p<0.025). The double-blind, international trial enrolled 143 women with biopsy-proven CIN grade 2/3. Data were presented at the International Society of DNA Vaccines meeting in San Diego. more >>

Researchers publish data on Kalydeco/lumacaftor interaction

Data from a pair of in vitro studies published in Science Translational Medicine on Wednesday show cystic fibrosis drug Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reduced the correction efficacy of the company's lumacaftor (VX-809) in human cells with two copies of the delta F508 mutation in the CF transmembrane conductance regulator (CFTR) gene. In a statement, Vertex said while the "preclinical experiments represent interesting cell biology that can inform our research efforts, what doctors and patients care about -- and what we're focused on -- is the benefit the combination has on people with CF." more >>

   POLITICS & POLICY

Non-profits call for Medicare policy reforms and lower drug prices

Reinstating Medicare rebates would save an estimated $141.2 billion over 10 years, according to a report released by Social Security Works and the Medicare Rights Center. The report outlines policy options to cut costs for Medicare, including restoring Medicare prescription drug rebates and allowing Medicare to negotiate drug prices for Part D. more >>

Burwell hires Dach as senior counselor

HHS Secretary Sylvia Burwell hired Leslie Dach as senior counselor, a new position. He will work on policy issues and strategic initiatives and will help with the second open enrollment period for health insurance through the health exchanges. Dach was EVP of corporate affairs at Walmart Stores Inc. (NYSE:WMT). The second open enrollment period is slated to start Nov. 15. more >>

Stakeholders ask Congress for more transparency in patient data

Stakeholders requested that FDA allow pharmaceutical companies to share more information with physicians about real-world drug usage so they can make more informed choices to provide better patient care. During a Tuesday hearing held as part of the U.S. House of Representatives Energy and Commerce Committee's Path to 21st Century Cures initiative, stakeholders discussed the discovery, development and delivery cycle and the importance of transparent collaboration to bring better treatments to patients sooner. more >>

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BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS

BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS
COVER STORY

AbbVie's plan B

Given escalating competition in HCV and MS, Shire could be AbbVie's plan B for growth after the inversion debate is over and forgotten.

PRODUCT DISCOVERY & DEVELOPMENT

Seamless solution in AML

Why Cyclacel, FDA created a novel protocol to attract and keep patients enrolled in Phase III testing for sapacitabine in AML.

EMERGING COMPANY PROFILE

Edico: Processing genomes

Edico is developing a processor that analyzes next-generation sequencing data in less than half an hour without sacrificing accuracy.

Envisia: Ophthalmic nanotechnology

Envisia's ophthalmic implants seek to overcome problems with existing drugs including frequent dosing and poor compliance.

POLITICS AND POLICY

Debating drug pricing

PhRMA, BIO, AHIP, National Coalition on Health Care debate the cost of providing access to Sovaldi and how to price specialty drugs.

FINANCE

Yellen or Yawning?

Buysiders' long-term outlook unchanged by Yellen's remarks on biotech

A little debt'll do 'ya

Why ZS Pharma added modest debt deal on top of big IPO

UCB's better housekeeping

Why UCB tapped European Investment Bank to fund six pharma programs

Analyst tracks

Biotech investor, banker and analyst personnel changes

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