Depomed Inc. boosted its pain portfolio with the purchase of Nautilus Neurosciences Inc.’s migraine drug, Cambia (diclofenac potassium for oral solution) for $48.7 million. Nautilus is eligible for an additional $5 million payment based on achievement of sales milestones. Cambia is the only single agent non-steroidal anti-inflammatory specifically indicated for migraine, with $18 million in sales over the past 3 months.
“We see Cambia as a differentiated asset,” Depomed CEO Jim Schoeneck told BioWorld Today. “We thought that it was attractive and had a good niche in the marketplace.”
Triptans are the most commonly used medications for migraines, either alone or in combination with other drugs. That class includes sumatriptan (Imitrex, Glaxosmithline plc), rizatriptan (Maxalt, Merck & Co. Inc.), zolmitriptan (Zomig, IPR Pharmaceuticals Inc.) and others.
Schoeneck said that even with a relatively small sales force of 35, Bedminster, N.J.-based Nautilus has seen 35 percent year-over-year prescription growth of the product.
“We’ve also been able to secure settlements with generic filers,” Schoeneck said. The product is not expected to enter the generic market until 2023, giving it a long term patent exclusivity.
In addition to sales and patent life, Depomed was attracted to the product by synergies with its existing portfolio. “We call primarily on pain specialists and neurologists,” Schoeneck said. “It’s a great fit.”
Depomed markets Gralise (gabapentin) tablets for postherpetic neuralgia, Zipsor (diclofenac potassium) for acute pain and Lazanda (fentanyl nasal spray) for cancer pain. Its pipeline includes a Phase I/II product, DM-1992, for Parkinson’s disease, as well as a number of partnered products in Type II diabetes, pain, and other indications.
Cambia is a powdered formulation of diclofenac designed to be quickly absorbed and fast acting. The drug is packaged as a single-use powder that can be kept in a pocket or purse and mixed with water for quick relief with onset of a migraine.
“The product not only helps the pain it also helps with sensitivity to light and sensitivity to sound that people with migraine often get,” Schoeneck said.
Depomed, which is headquartered in Newark, Calif., has acquired Cambria in the midst of a flurry of activity in the migraine field, including numerous clinical trials, financings, and licensing deals.
In June, Zogenix Inc., of San Diego, inked an exclusive co-promotion agreement for Migranal (dihydroergotamine mesylate) nasal spray in the U.S. with Valeant Pharmaceuticals International Inc., of Laval, Quebec. Under the terms, Zogenix’s sales force will begin selling the migraine product to prescribers, primarily composed of neurologists, headache specialists and related nurse practitioners and physician assistants, in late July. The initial term of the deal runs through Dec. 31, 2015, and can be extended by mutual agreement. Valeant will record all product revenues, while Zogenix will be compensated in the form of a quarterly service fee that is calculated as a percentage of net sales over a baseline amount.
The FDA accepted a new drug application from Redhill Biopharma Ltd., of Tel-Aviv, Israel, for RHB-103, an oral thin film formulation of rizatriptan, for the treatment of acute migraine, co-developed by Intelgenx Corp., of Saint Laurent, Quebec. The FDA has assigned a standard 10-month review period with a target date for completion of Feb. 3, 2014.
Trigemina Inc., of Moraga, Calif., completed a $4.5 million Series A financing, led by existing Chilean-based investor Aurus, through its Aurus Bios Fund, and supplemented by a grant awarded by the government of Chile. Proceeds will be used to fund the completion of the Phase II TRIG-05 trial evaluating the company’s lead drug candidate, TI-001, an intranasal oxytocin therapy, for the treatment of chronic migraine.
Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., and Optinose AS, of Oslo, Norway, inked an exclusive North American license agreement for the development and commercialization of Optinose’s Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. Under the terms, Optinose received an up-front cash payment of $20 million and is eligible to receive certain shared development costs and up to an additional $90 million in total linked to clinical, regulatory and commercial milestones. Avanir also would make tiered royalty payments if the product is approved and sold in North America. Avanir assumes responsibility for regulatory, manufacturing, supply chain and commercialization activities for the product, now named AVP-825, and both parties will work together on the remaining activities in support of a new drug application submission, expected in early 2014.
Transcept Pharmaceuticals Inc., of Point Richmond, Calif., rejected an unsolicited proposal from Retrophin Inc., of New York, to acquire all outstanding shares of Transcept for $4 per share. The board of directors said that the proposed acquisition is not in the best interests of Transcept or its stockholders. In other news, Transcept signed a license agreement with Shin Nippon Biomedical Laboratories Ltd., of Japan, to develop and commercialize TO-2070 for acute migraine. The drug is designed to deliver dihydroergotamine through a nasal powder drug delivery system. Transcept paid an up-front fee of $1 million, with potential development milestones up to $6.5 million. After launch of the product, milestones connected to annual sales levels could total up to $35 million. Transcept will also pay tiered, low double-digit royalties on annual net sales.