Nigel's new ark

KUOPIO, Finland—Stepping off ARK Therapeutics shortly after the company's lead gene therapy, Cerepro, was rejected by the European Medicines Agency, Nigel Parker, CEO of FKD Therapies, has struck a deal with Merck & Co. Inc. to develop and commercialize a recombinant adenoviral interferon alfa 2b (rAd-IFN) for the treatment of superficial bladder cancer.

The agreement also provides FKD with the option to develop two other investigational programs, a recombinant adenoviral p21 (rAd-p21) to treat glaucoma surgery failure and conditionally replicating adenoviral technology (CRAV) for the treatment of solid tumors. In return, Merck has taken an equity stake in FKD.

FKD was established in February 2011 and shortly afterwards secured $16 million in private funding underwritten by Wölbern Invest and supported by the Finnish Funding Agency for Technology and Innovation.

The lead interferon compound, rAd-IFN, has completed Phase I clinical trials for the treatment of superficial bladder cancer, the fourth most common cancer in the world.

"We're now focusing on our Phase II program, predominately in the U.S.," says Parker, "and looking at Phase III supply as well."

He also notes that FKD is still trying to "get the phones to work," liaise between Finnish and U.S. operations and transfer the requisite technology from Merck.

Bladder cancer affects some 75,000 new patients each year in the U.S. alone and is the most costly cancer to treat on a lifetime survival basis.

Parker says, "Our development portfolio and cash reserves have now established FKD as a key player in the field of gene-based medicines. The deal with Merck illustrates the interest in developing this advanced area of biomedicines and provides a powerful endorsement of the management team, all of who have extensive experience in this field. We look forward to commencing development of the portfolio, starting with the Phase II clinical trial for rAd-IFN."

Joining Parker on the new company's management team are Prof. Seppo YlaHerttuala (consultant CSO), Gillian Gregory (development and regulatory director) and Prof. Alan Boyd (clinical development consultant).

According to published reports, Merck became disenchanted with gene therapy after its acquisition of Schering-Plough and decided its best strategy would be to find a new home for the technology. Dr. Meeta Chatterjee, head of global out-licensing and asset management at Merck adds that, "FKD has established an impressive team of experts in the gene therapy field with the motivation and funding to advance the rAd-IFN gene therapy program towards the market. Through this agreement with FKD, we believe rAd-IFN is well-positioned to maximize its therapeutic potential."

The efficacy of Interferon alfa 2b protein therapy for the treatment of bladder cancer has been limited by its mode of administration as bladder concentrations fall below detectable levels 24 hours after treatment. Parker notes that interferon in protein form has been approved in dozens of countries. FKD's rAd-IFN is an adenoviral (Ad5) vector-based gene medicine, containing the interferon alfa 2b transgene.

Administered as one dose with Syn3, an excipient to improve transfection, the adenovirus is designed to carry the interferon gene into the bladder wall cells where it penetrates cells and expresses interferon protein locally. Evidence suggests that the rAd-IFN may produce a therapeutic concentration of interferon measurable for seven days, Parker states. The completed Phase I trial involved 14 patients given a single therapeutic administration into the bladder after tumor resection. Three of the patients (43 percent) experienced a complete response (no tumor recurrence) at three months, with an average 23-month durability in patients receiving one repeat dose at three months.

Merck sells its interest in joint venture with J&J

WHITEHOUSE STATION, N.J.—Merck also announced in late September that the company has sold its 50-percent interest in the Johnson & Johnson-Merck Consumer Pharmaceuticals Co. joint venture (JJMCP) to Johnson & Johnson (J&J) affiliates, McNEIL-PPC Inc., McNEIL MMP LLC and Johnson & Johnson Inc. The venture between Merck and J&J was formed in 1989 to develop, manufacture, market and distribute certain over-the-counter (OTC) consumer products in the United States and Canada.

In a press release announcing the sale, Merck said it decided to sell its interest in the joint venture to enable the company to fully focus on building the long-term growth prospects of the wholly owned consumer products division that had been part of Schering-Plough Inc. prior to the 2009 merger. Under the agreement, Merck will receive a one-time payment of $175 million. Merck's rights to the Pepcid brand outside the United States and Canada are not affected by this transaction.

Merck said termination of the JJMCP venture also gives it greater freedom to operate in the OTC consumer sector, fully exploit its pipeline of Rx-to-OTC switches and pursue OTC licensing activities in the United States and Canada.

Following the transaction, J&J will own the venture's assets, which include the exclusive rights to market OTC Pepcid, Mylanta, Mylicon and other local OTC brands where they are currently sold in the United States and Canada. The partnership assets include a manufacturing facility in Lancaster, Pa.