MISSISSAUGA, Ontario—Targeted toward expanding its dermatology pipeline, Cipher Pharmaceuticals Inc. has made an upfront payment of $500,000 to acquire intellectual property (IP) and other assets of Hershey, Pa.-based life-sciences company Melanovus Oncology Inc. Cipher has also agreed to a later payment, as yet unspecified, of certain IP expenses related to patent prosecution and maintenance.
The lynchpin of this innovative deal is Cipher’s access to seven preclinical compounds for the treatment of melanoma and other cancers.
In 2012, Melanovus acquired an exclusive global license to a library of compounds and related IP from the Pennsylvania State University (Penn State) Research Foundation, originating from work done by Dr. Gavin Robertson, professor of pharmacology, pathology, dermatology and surgery at Penn State University and director of the Penn State Hershey Melanoma Center.
“The acquisition of these preclinical assets demonstrates our commitment to building a complete dermatology franchise and investing prudently in potentially transformative compounds,” says Shawn O’Brien, president and CEO of Cipher. “Melanoma is the deadliest of the skin cancers, and incidence rates have been rising for more than 30 years. We look forward to continuing the work of Dr. Robertson and his team, who have invested more than 12 years in the development of these promising compounds.”
O’Brien tells DDNews that “acquiring the skin cancer and melanoma preclinical products from Melanovus Oncology fits within our strategy.”
“We believe in the future that new oral and topical agents will be used in addition to the surgical or laser removal of skin and melanoma cancers by dermatologists,” he adds. “Some of the seven assets we purchased have potential to play in this new market. Since many pathways are involved in skin and melanoma cancers, some of these seven agents may have a future application in other types of cancers. Our license with Penn State allows us to commercialize these seven compounds for all types of cancers. We will remain focused on skin cancers and partner for the other cancer indications.”
“As we acquire assets and companies to enhance our ability to commercialize dermatology products directly in the U.S. and Canada, and partner them out beyond North America, our ‘complete dermatology franchise’ will expand to cover both medical and aesthetic dermatology products which are driven primarily by dermatologists,” O’Brien explains. “So our dermatology franchise will expand beyond the skin cancer, impetigo, psoriasis and acne products we have today.”
Cipher will pursue preclinical studies leading to Investigational New Drug (IND) status with the U.S. Food and Drug Administration (FDA), Health Canada and other health authorities. The plan for the development of the remaining compounds in the portfolio has not yet been established.
The approval process is “about the same in most cases; however, sometimes the Canadian regulatory authorities will accept European data that would not get approved by the FDA, as it may not have a placebo arm in the studies which the FDA requires,” O’Brien says. “Nanolipolee-007 is our lead preclinical candidate with an active plan to complete the IND-enabling work over the next 12 to 16 months.”
Nanolipolee-007 is a liposomal formulation of a plant-derived compound that is a first-in-class cholesterol-transport inhibitor which has demonstrated anti-proliferative activity against certain melanoma cell lines (including B-raf resistant strains) in vitro as well as in early in-vivo mouse studies.
In the short term, O’Brien wants to “establish a fully operational commercial dermatology ebusiness in the U.S. by the end of 2015, continue the IND-enabling work on Nanolipolee-007 and achieve our 2015 financial goals.”
Cipher’s long-term goals related to the Melanovus Oncology agreement are to achieve FDA approval for Nanolipolee-007 in advanced melanoma, develop a series of topical and oral products for the new adjuvant skin cancer market and monetize the full value of the seven compounds with the potential non-dermatology cancer indications through partnerships, O’Brien says.
On Jan. 7, Cipher expanded its dermatology pipeline with the licensing of the Canadian rights to Ozenoxacin, a topical treatment for adult and pediatric patients with impetigo, from Ferrer, a privately held Spanish pharmaceutical company.
In 2013, Ferrer successfully completed a first Phase 3 clinical trial of Ozenoxacin in adult and pediatric patients aged two years and older with impetigo. The study demonstrated the superiority of Ozenoxacin 1-percent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit.
In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three/four), according to Cipher. The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and pediatric populations.
Ferrer commenced a second Phase 3 trial of Ozenoxacin in June 2014, anticipating the trial to be completed sometime during the first quarter of this year.
“We are pleased to partner with Ferrer to bring this novel product to the Canadian market, targeting impetigo due to bacterial skin infections, which remains a common problem in infants and young children,” O’Brien stated in a news release.
Under the terms of the agreement, Ferrer will receive an upfront payment and is eligible for development milestones and revenues from product sales in Canada. Ferrer will manufacture Ozenoxacin and deliver the finished product to Cipher.