Biotech News Bytes: Johnson & Johnson, CombinatoRx, Covidien

On 5/26/09, Johnson & Johnson (NYSE: JNJ) announced that the FDA extended by three months the review timeline for the Biologic License Application (BLA) for Stelara (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market Stelara for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

The BLA amendment was submitted by JNJ within three months of the original PDUFA decision date and relates to testing results to establish the product's shelf life. The FDA has requested no additional clinical trials for Stelara. Bristol-Myers (BMY) is set to receive UltiMAb Royalties on sales of Stelara as part of its July 2009 Medarex acquisition.

On 9/25/09, the FDA approved Stelara (ustekinumab) for the treatment of adults who have a moderate to severe form of psoriasis. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body’s own antibodies that are produced as part of the immune system and treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

On 9/24/09, ThromboGenics [EBR: THR.BR] announced that it has completed the enrolment of its U.S. Phase 3 trial (TG-MV-006) evaluating microplasmin for the non-surgical treatment of eye disease. The second Phase 3 study with microplasmin (TG-MV-007) is recruiting patients in the U.S. / Europe and is due to complete enrolment during 1H10. The Phase 3 program for microplasmin involves two clinical trials, which are taking place in the U.S. (TG-MV-006 trial) and Europe / U.S. (TG-MV-007 trial).

Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125 mcg. of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion (a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye). Results from the TG-MV-006 study are expected to be presented by mid-2010.

Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions such as macular hole formation, and some forms of macular edema. Vitreomacular adhesion is also associated with a much poorer prognosis in certain major eye conditions, including diabetic retinopathy and Age-related Macular Degeneration (AMD).

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using optical coherence tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina. Based on its experience and discussions with the FDA, OCT was selected as the main assessment technique for the Phase 3 program as it provides results which have greater clinical relevance.

On 7/1/09, CombinatoRx (NASDAQ: CRXX) and Neuromed Pharma (privately held) announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Final merger terms will be adjusted based upon the outcome of a pending FDA decision for Neuromed’s New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients.

The rights to Exalgo have been acquired by a subsidiary (Mallinckrodt) of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date of 11/22/09 for a possible FDA decision.

On 9/23/09, a FDA Advisory Panel was held to review the Exalgo NDA. During the meeting, information was provided on Exalgo Alliance, which is the proposed Risk Evaluation and Mitigation Strategy (REMS) for Exalgo. Combined with Exalgo's proposed labeling, Exalgo Alliance will help ensure the appropriate access, prescribing, dispensing and use of Exalgo. “We are pleased that the committee endorsed the REMS program as proposed by Covidien and Neuromed," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "The committee has asked us to look at the possibility of a phased rollout, and we look forward to discussing this input with the agency and other pain management experts."

Disclosure: No positions.