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Insmed Advances to Clinic with First Follow-On Biologic, INS-19
(BioWorld Today Via Thomson Dialog NewsEdge) Even as the FDA collaborates with federal lawmakers on legislation to give the agency clear regulatory approval over follow-on biologics, Insmed Inc. steadily is moving forward with its first follow-on product, a version of Amgen Inc.'s Neupogen.
The Richmond, Va.-based company received approval from the UK's Medicines and Healthcare Products Regulatory Agency to start a Phase I trial of INS-19, a recombinant form of granulocyte-colony stimulating factor (G-CSF). That study will test Insmed's candidate against Neupogen for safety and to establish bioequivalence, with results expected in the second half of this year.
Then, pending positive Phase I data, the company plans to approach the FDA to establish a protocol for initiating a U.S. Phase III trial. And therein lies the challenge.
There is no clear regulatory pathway yet established for follow-on biologics, also known as biosimilars. Some products have made it through to market, including Omnitrope (somatropin [rDNA origin]) from German firm Sandoz GmbH. Sandoz managed to gain approval of that product, a follow-on version of a growth hormone drug, in mid-2006 after suing the FDA over delays in reviewing the application. At that time, the agency indicated that it would continue considering follow-on biologics applications on a case-by-case basis. (See BioWorld Today, June 1, 2006.)
But if legislation does move forward on establishing a regulatory pathway, Insmed could be one of the few early firms treading new ground.
"We think we have a pretty good handle" on what the biosimilars process will entail, said Steve Glover, president of Insmed Therapeutic Proteins. "When we put together a plan in the first half of 2007, we looked at the marketplace and we looked at the regulatory environment and the progress, or lack of progress" in establishing a clear procedure.
"We also looked closely at the approval of Omnitrope and the battle around that," he added.
Insmed also has been an active participate in the congressional debate. CEO Geoffrey Allan has testified before lawmakers twice, and earlier this year, Insmed was one of 30 stakeholders in the biotech industry, health care and patient communities to receive a questionnaire from the House Subcommittee of Health seeking input on possible legislation to establish a follow-on biologics pathway. The six pages of questions cover a range of issues, from the science surrounding biosimilars to potential economic impact to incentives, and the company aims to submit its responses before the April 22 deadline.
Despite having to deal with a "lot of different views and agenda," Glover said he believes the committee is "going about it in a holistic way," looking at the impact of biosimilars legislation on science, intellectual property and requirements needed to provide patient access to those medications.
In February, the Bush administration unveiled the 2009 federal budget package, in which it stated plans to seek regulatory authority for the FDA to approve follow-on biologics, to be financed through user fees. (See BioWorld Today, Feb. 11, 2008.) Biosimilars legislation was introduced in both the House and the Senate in 2007, and Insmed executives are among those hoping to see legislation passed this year. "Obviously, we're hopeful" that it will pass, "but this is an election year," Glover said.
To date, one of the sticking points has been the proposed inclusion of a provision aimed at ensuring data exclusivity for a period of time. In March, Reps. Anna Eschoo (D-Calif.) and Joe Barton (R-Texas) introduced a follow-on biologics bill that would provide 12 years of data exclusivity, though opponents, including the Generic Pharmaceutical Association, have rallied against including that 12-year data exclusivity protection, arguing that it protects pharma profits at the expense of the consumer. (See BioWorld Today, March 17, 2008.)
When asked if he was in favor of the 12-year exclusivity period, Glover said, "Not necessarily," adding that Insmed's stance is that the position for biologics "should be the same as for small molecules," which provides five years of exclusivity for new chemical entities.
Right now, the firm is focused on advancing INS-19, which, like Neupogen, is a synthetic version of human G-CSF designed to mimic naturally occurring G-CSF to treat neutropenia, conditions involving a drop in a patient's neutrophils due to chemotherapy treatment, bone marrow transplants or other causes. Preclinical studies of Insmed's drug have shown that in terms of pharmacological and toxicological profiles, it is comparable to Neupogen, a drug that generated about $900 million in U.S. sales for Thousand Oaks, Calif.-based Amgen in 2007.
Insmed's existing protein manufacturing facility and existing clinical and regulatory expertise has allowed the firm to quickly move from cell lines to the clinic, Glover said, adding that INS-19 was ready for human trials in about a year. And following "rapidly behind" that program is INS-20, a follow-on pegylated version of G-CSF.
The plan is to "push forward with those early stage programs very quickly," Glover said, with the goal of getting product approval one year prior to the expiration of the innovator's patent. So for INS-19, Insmed hopes to have the FDA's blessing in 2012. Neupogen's patent expires in 2013.
"We're not looking to take any of the innovator's time away," Glover said, adding that Insmed was sympathetic to the innovator's standpoint as a firm that also has an innovative pipeline as well, with its work on Iplex, a complex of recombinant human insulin-like growth factor 1 (IGF-1) and its binding protein IGFBP-3. "So it's interesting for us to be in this debate because we have stakes in both sides of the ground," he told BioWorld Today.
The company began working on its follow-on biologics portfolio about a year ago, after settling a patent fight with Brisbane, Calif.-based Tercica Inc. over IGF-1 deficiency drugs. The settlement called for Insmed to remove its drug, Iplex, from the market in short stature, leaving only Tercica's Increlex product, partnered with South San Francisco-based Genentech Inc., on the shelf for that orphan indication. (See BioWorld Today, March 8, 2007.)
But Insmed hasn't given up on Iplex. The firm continues to develop the drug in neuromuscular disorders, such as myotonic muscular dystrophy, a common form of adult muscular dystrophy, and is enrolling patients in a Phase II study.
Shares of Insmed (NASDAQ:INSM) closed at 70 cents Wednesday, up 4 cents.
The company reported a net loss of $3.3 million, or 3 cents per share, for the fourth quarter of 2007. As of Dec. 31, it had cash, equivalents and short-term investments totaling $16.5 million. n
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