Chairman and CEO Kenneth Frazier of Merck & Co. Inc. (NYSE:MRK), CEO George Scangos of Biogen Inc. (NASDAQ:BIIB) and other biopharma CEOs are slated to meet with President Obama on Thursday to discuss the Trans-Pacific Partnership agreement, multiple pharma industry sources told BioCentury. Frazier is chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA), and Scangos is PhRMA's chairman-elect.
The White House, which requested the meeting, is launching an all-out effort to attract support for the trade deal. Obama will be speaking to a skeptical audience. PhRMA and the Biotechnology Industry Association (BIO) have expressed strong disappointment in TPP because it does not require other countries to adopt a 12-year market exclusivity term for biologics (see BioCentury Extra, Oct. 5).
The agreement allows parties to the agreement to either provide a minimum of eight years of market exclusivity for biologics, or to provide five years of exclusivity along with additional regulatory and administrative steps that could further delay competition from biosimilars. The agreement does not prevent countries from adopting longer exclusivity periods, and it would not affect the 12 years provided by the United States for biologics.
Despite the disappointment expressed by drug companies, Hillary Clinton cited benefits to the industry as one of the reasons she opposes TPP. In an interview with PBS NewsHour on Wednesday, Clinton said she is "worried that the pharmaceutical companies may have gotten more benefits, and patients and consumers fewer" from TPP. She added that based on "what I know about it, as of today, I am not in favor of what I have learned about it."
Lion Biotechnologies Inc. (NASDAQ:LBIO) gained $0.80 (14%) to $6.43 on Wednesday after it received an exclusive, worldwide license to use NIH's tumor-infiltrating lymphocytes (TIL) in four new oncology indications, amending an existing agreement.
The amendment gives Lion rights to develop TIL therapies to treat bladder, lung, breast and HPV-associated cancers. In February, Lion acquired an exclusive license from NIH to develop TIL immunotherapies to treat metastatic melanoma.
CEO Elma Hawkins told BioCentury the company expects to submit an IND to FDA by YE15 to treat one or two HPV-associated cancers.
Last month, Lion started a Phase II study of lead program LN-144, an autologous T cell therapy that uses TILs derived from the patient's tumor, to treat metastatic melanoma.
NIH will receive an upfront payment in two tranches, and is eligible for milestones and royalties. Specific financial details were not disclosed.
Hawkins said TILs offer advantages over other immunotherapies because the tumor-infiltrating cells recognize a variety of tumor antigens. Hawkins said the company targeted both melanoma and the new tumor indications because they have high rates of somatic mutations representing diverse tumor antigens.
Genocea Biosciences Inc. (NASDAQ:GNCA) gained $0.49 to $6.39 after it said GEN-003 significantly reduced viral shedding in an interim analysis of a Phase II trial to treat herpes simplex virus-2 (HSV-2), meeting the study's primary endpoint.
Genocea reported a 58% reduction in viral shedding from baseline to six months after treatment with 60 ug per protein of GEN-003 and 75 ug of its Matrix-M2 adjuvant, the study's best performing dose (p<0.0001). Five of six GEN-003 doses significantly reduced genital lesions from baseline at rates ranging from 43-69%.
The company said the proportion of lesion-free patients at six months was comparable to that observed with oral antiviral therapies, about 30-50%. Time to first recurrence ranged from 152 days to >180 days.
Genocea said in May that GEN-003 met the study's primary endpoint of reducing viral shedding during a 28-day observation period after completion of dosing (see BioCentury Extra, May 20).
Genocea said GEN-003 was well tolerated with no treatment-related serious adverse events. Data from the study will be presented on Friday at IDWeek in San Diego. The company said it expects 12-month data in 1Q16, and hopes to hold an end-of-Phase II meeting with FDA in late 2016.
Patients received three doses of GEN-003 in the 310-patient study at 21-day intervals. On a conference call with investors, CEO Chip Clark said the immunotherapy could replicate the convenience of an episodic herpes treatment regimen with the efficacy of chronic antiviral therapy.
GEN-003 is a T cell vaccine consisting of the infected cell polypeptide 4 (ICP4) and gD2 antigens from HSV-2 combined with the saponin-derivative adjuvant Matrix-M2.
Aclaris Therapeutics Inc. (NASDAQ:ACRS) gained $0.05 to $11.05 in its first day of trading after raising $55 million through the sale of 5 million shares at $11 in an IPO underwritten by Jefferies; Citigroup; and William Blair. The IPO price valued Aclaris at $213.5 million.
Aclaris proposed to raise up $86.3 million in August. Last month, it said it hoped to sell 5 million shares at $14-$16. At $15, it would have raised $75 million and been valued at $291.1 million.
Aclaris' IPO is at least the fourth life sciences listing since Sept. 30 to price below its proposed range (see BioCentury, Oct. 5).
Aclaris raised $40 million in a series C round last month. The company said in a Sept. 25 regulatory filing that it plans to start three Phase III studies in 1Q16 of A-101, a high-concentration hydrogen peroxide topical solution to treat seborrheic keratosis. In a filing earlier in September, the company said it intended to start the studies this half.
Also last month, Aclaris acquired rights to preclinical Janus kinase (JAK) inhibitors from Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) to treat dermatological conditions (see BioCentury Extra, Sept. 9).
Euroscreen S.A. (Brussels, Belgium) raised EUR 16 million in a series B round co-led by new investors SFPI-FPIM and Fund+. New investor Capricorn Health-Tech Fund also participated, as did existing investors Vesalius Biocapital II Partners; SRIW; and BNP Paribas Fortis Private Equity.
Euroscreen expects data in 3Q16 from three parallel European Phase II studies of lead compound ESN364 to treat menopausal hot flashes, polycystic ovary syndrome and uterine fibroids. The company also hopes to file an IND in the U.S. for the neurokinin-3 (NK3) receptor (TACR3; NK3R) antagonist.
The Trans-Pacific Partnership agreement will not require Australia to provide any additional exclusivity for biologics beyond the five years of data protection it currently provides, according to a document released by the Australian Department of Foreign Affairs and Trade.
"Australia has negotiated protections that are consistent with existing Australian law and practice," the document reads. "Australia is not required to change any part of its current law, including data protection for biologics, or our patent regime."
The document describes a two-track scheme for protecting biologics. Under one track, the 12 nations that are parties to the TPP "can choose to provide effective market protection though at least 8 years of data protection," the document states. "Alternatively, Parties can choose to provide effective market protection through at least 5 years of data protection, along with other measures, including existing measures in the case of Australia, and recognising market circumstances. These measures and circumstances include regulatory settings, patents, and the time it takes for follow-on medicines to become established in the market."
Australia "will follow the 5 year option, which reflects our current system and requires no changes," the document says.
The government also reported that TPP "allows transition periods for countries that need to change their laws in order to comply with the TPP's provisions on biologics," but said that Australia "does not need to do so."
The document also says countries that ratify TPP have committed to "consult after ten years, or otherwise decide to review the TPP provisions on biologics, with a view to providing effective incentives for the development of biologics, as well as to facilitate timely access to medicines, including biosimilars."
EMA's Committee for Orphan Medicinal Products reappointed Bruno Sepodes as chair and Lesley Greene as vice-chair. Each will serve a new three-year term that begins this month.
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