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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said once-weekly subcutaneous dupilumab met the primary endpoint of reducing the proportion of patients who experienced an asthma exacerbation through week 12 vs. placebo in a Phase IIa trial to treat moderate to severe persistent asthma (5.8% vs. 44.2%, p<0.001). The double-blind, U.S. trial enrolled 104 patients whose asthma was not well controlled with inhaled glucocorticosteroids and long-acting beta agonist (LABA) therapy and who had elevated blood or sputum eosinophil levels. Data were published in the New England Journal of Medicine and presented at the American Thoracic Society meeting in Philadelphia.
By mid-year, the partners plan to start a Phase IIb trial of dupilumab to treat moderate to severe uncontrolled asthma. Data from a Phase IIa trial of dupilumab to treat moderate to severe atopic dermatitis are also expected this year, while a Phase IIb trial is slated to start mid-year. Sanofi and Regeneron are co-developing the human mAb targeting the alpha subunit of the IL-4 receptor (CD124) under a 2007 deal.
Regeneron was off $3.68 to $259.96 on Tuesday.
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The European Commission approved an MAA from Baxter International Inc. (NYSE:BAX) for HyQvia as replacement therapy for adults with primary immunodeficiencies. The product is also approved as replacement therapy in adults with in myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections. Baxter said it plans to launch the product in the EU this year starting with Germany, followed by Ireland and the U.K.; the company said it does not disclosing pricing by product. Baxter is partnered with Halozyme Therapeutics Inc. (NASDAQ:HALO) to develop the subcutaneous formulation of IV Gammagard, an IgG antibodies plasma-based therapy, and rHuPH20, a recombinant human PH20 hyaluronidase enzyme, under a 2007 deal. Halozyme was up $0.02 to $7.59 on Tuesday.
Last August, FDA issued a complete response letter for a BLA for the product, which is known as HyQ in the U.S., and asked for additional preclinical data to address concerns about non-neutralizing antibodies generated against rHuPH20. Baxter said in January that it plans to meet with FDA this quarter to discuss interim data from animal studies (see BioCentury Extra, Aug. 1, 2012).
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Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for accelerated assessment an MAA for sofosbuvir to treat chronic HCV infection. An accelerated assessment shortens the review period to 150 days from 210. Gilead said the MAA covers the use of sofosbuvir in combination with ribavirin as an all-oral therapy to treat HCV genotypes 2 and 3 infection; and sofosbuvir in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 4, 5 and 6 infection in treatment-naïve patients.
Gilead submitted an NDA to FDA for sofosbuvir for the same indications In April. Sofosbuvir is a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor. Gilead, which announced the news after market close, was up $0.73 to $56.47 on Tuesday.
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Veloxis Pharmaceuticals A/S (CSE:VELO) said EMA accepted for review an MAA for LCP-Tacro tacrolimus to prevent organ rejection in kidney transplant patients. The company said it expects a decision on the application next year. Veloxis also plans to submit an NDA to FDA for the product, which comprises tacrolimus delivered using the biotech's MeltDose technology, next half. Veloxis was up DKK0.03 to DKK0.70 on Tuesday.
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Roche (SIX:ROG; OTCQX:RHHBY) said it declined to exercise its option to license STX209 from Seaside Therapeutics Inc. (Cambridge, Mass.) for autism after Seaside reported earlier this month that the compound missed the primary endpoint in the Phase IIb Study 209AS208 to treat autism spectrum disorders (ASD). Roche had received the option for the oral selective GABA B receptor agonist last year as part of a deal to develop disease modifying treatments for fragile X syndrome and ASD (see BioCentury Extra, May 1).
Separately, Seaside discontinued two open-label extension studies evaluating STX209 in ASD patients and fragile X patients "due to resource limitations at Seaside." The company declined to disclose additional details, including how much cash it has or development plans for STX209. Earlier this month, Seaside had said it planned to confirm the 209AS208 results by starting another controlled trial of STX209 in patients with ASD, while data from a pair of Phase III trials of STX209 to treat fragile X syndrome are expected this year.
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Biogen Idec Inc. (NASDAQ:BIIB) submitted a BLA to FDA for Plegridy peginterferon beta-1a (BIIB017) to treat relapsing forms of multiple sclerosis (MS). The company said it expects to submit MAA to EMA "in the coming weeks." Biogen Idec was up $6.15 to $231.33 on Tuesday.
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Novo A/S (Hellerup, Denmark) acquired infectious disease company Xellia Pharmaceuticals A/S (Oslo, Norway) from private equity firm 3i Group for about $700 million. In 2008, 3i acquired Xellia, which develops and manufactures active pharmaceutical ingredients and finished dosage forms of antibacterials and antifungals. Xellia also is developing three different device delivery systems: metered dose pumps for topical formulations, ready-to-use injectable bag systems for use in hospitals and aqueous droplet inhalation devices for out-patient use. The company will move its headquarters to Copenhagen, Denmark. The deal is slated to close in 3Q13.
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Merck & Co. Inc. (NYSE:MRK) said it will repurchase about $5 billion in stock, or about 99.5 million shares, from Goldman Sachs under an accelerated share repurchase program. The program is slated to be completed by Nov. 25 and is part of a $15 billion share repurchase program the pharma announced earlier this month. Merck repurchased $772 million in shares in the first four months of the year and has about $16.1 billion remaining under existing share repurchase programs. As of March 31, the pharma had $16 billion in cash.
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Cancer company Epizyme Inc. (Cambridge, Mass.) amended its IPO and said it plans to sell 4.3 million shares at $13-$15. At the $14 mid-point, Epizyme would raise $60 million and be valued at $375 million. Earlier this month, Epizyme said it planned to sell 4.3 million shares in the IPO. Citi; Cowen; Leerink; JMP Securities; and Wedbush PacGrow are underwriters. Epizyme proposed to raise up to $69 million in the offering in April.
Epizyme's EPZ-5676 is a histone methyltransferase DOT1L (DOT1L) inhibitor in a Phase I trial to treat leukemia with rearrangements in the histone methyltransferase myeloid-lymphoid or mixed-lineage leukemia (MLL; HRX) gene. Celgene Corp. (NASDAQ:CELG) has ex-U.S. rights to the product under a 2012 deal (see BioCentury, April 30, 2012).
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The French government's Fonds National d'Amorcage and the not-for-profit AFM-Telethon launched a seed fund to invest in biotherapeutics for rare diseases. The new fund, which will be managed by CDC Enterprises launched with EUR 50 million ($64.2 million) and has a EUR 120 million ($154 million) target. The fund plans to invest EUR 3-EUR 10 million ($3.9-$12.8 million) each in 12-15 companies. The partners said the majority of the investments will be in French companies.
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Novartis AG (NYSE:NVS; SIX:NOVN) said once-daily QVA149 met the primary endpoint of improving patient self-reported shortness of breath during daily activities as measured by Transition Dyspnea Index (TDI) scores from baseline to week six vs. placebo (p<0.001) in the Phase III BLAZE trial to treat chronic obstructive pulmonary disease (COPD). Data were presented at the American Thoracic Society meeting in Philadelphia. QVA149 is a fixed-dose combination of glycopyrronium bromide, an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). The BLAZE trial, which enrolled 247 patients with moderate to severe COPD, is part of the 10-trial Phase III IGNITE program of QVA149. Including BLAZE, QVA149 has met the primary endpoint in six of the trials. The ARISE, BEACON, RADIATE and LANTERN trials have not yet reported data.
Last year, Novartis submitted regulatory applications for QVA149 for COPD in Europe and Japan. Data from the BLAZE trial were not included in the submissions. Novartis plans to submit a regulatory application for QVA149 to FDA by the end of 2014.
Glycopyrronium bromide is approved for COPD in Europe, Japan, Canada and Australia as Seebri Breezhaler. Novartis plans to submit an NDA to FDA for the product in 2014. Novartis markets indacaterol in more than 100 countries, including the U.S. and those of the EU, for COPD. Novartis has global rights to develop and commercialize NVA237 from Vectura Group plc (LSE:VEC) and Sosei Group Corp. (Tokyo:4565) under a 2005 deal. Vectura was off a pence to 89p on Tuesday. The news was released after market close in Japan, where Sosei was off Y210 to Y5,010 on the day.
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FDA is holding a public meeting on July 25-26 to obtain stakeholder input on the agency's REMS program, including the issues and challenges associated with standardizing and assessing REMS. According to the meeting notice, the agency said it may establish standards to reduce "unnecessary variation" in REMS, though the agency noted that variations are sometimes appropriate to address "specific risks posed by particular drugs." FDA said it is aiming to make REMS more predictable and simpler to understand, implement and measure.
FDA is holding the meeting to meet performance goals under PDUFA V reauthorization. The agency said the meeting is also prompted by a February report from HHS's Office of the Inspector General that said FDA does not have enough data to evaluate whether REMS under the agency's REMS program are meeting their goals (see BioCentury Extra, Feb. 13).
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The Pharmaceutical Research and Manufacturers of America named Lori Reilly EVP of policy and research, effective June 7. Reilly, who is VP of policy and research at PhRMA, succeeds Rick Smith, who is retiring.
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