Oasmia Pharmaceutical, Uppsala, Sweden, has received a notification of Minor Use
status (MUMS) for Paccal® Vet. MUMS provides several benefits including a seven
year market exclusivity when registered and eligibility for conditional
approval.
Paccal® Vet, Oasmia's investigational product to treat cancer in dogs, has
received designation for Minor Use status by the US Food and Drug Administration
Center for Veterinary Medicine.
Minor use designation provides several benefits, among others:
Oasmia will be eligible to request “conditional approval,” to market Paccal® Vet
before collecting all necessary efficacy data, but after proving the drug is
safe. Conditional approval would allow Oasmia to market Paccal® Vet for up to
five years while collecting the required data.
Following FDA approval, designated new animal drugs are granted seven years of
marketing exclusivity, which means Oasmia would face no generic competition in
the marketplace for the approved use of the drug for that time.
Minor Use status1 for animal drugs is similar to Orphan Drug status for human
drugs. This designation applies to the indication “for the treatment of
non-resectable Grade II and III mast cell tumors that have not received previous
therapy, except corticosteroids, in dogs.” FDA made their decision after
assessing the data which Oasmia's previously submitted concerning the scientific
rationale and development plan for the product candidate.
Paccal® Vet also has Expedited Review status, a category reserved for products
that have the potential to provide important advances to animal health.
Expedited Review halves the amount of time allotted for FDA to evaluate the
safety and manufacturing data that must be accepted prior to applying for
conditional approval.
- We are very pleased to have received MUMS designation in which conditional
approval can be utilized. Each day in which we can reduce the time to the market
is extremely valuable for Oasmia and its US partners. The US market is the
largest for Paccal® Vet with about 100 000 dogs annually suffering from mast
cell tumors, says Julian Aleksov, CEO of Oasmia in a comment.
More information in regards to Minor Use can be found at FDA's homepage at:
http://www.fda.gov/cvm/minortoc.htm
About Paccal® Vet
With the retinoid based unique platform XR-17, Oasmia has managed to produce a
water soluble formulation of Paclitaxel (Paccal® Vet), that does not require
premedication and abolish Cremophor® EL related side effects. Two clinical
trials have been performed in client owned dogs with tumors refractory to
standard treatment. The results are very promising, both regarding tolerability
and tumor response. Moreover, the studies show that the findings in the dog are
supporting parallel trials in humans, regarding pharmacokinetics and reported
side effects. The studies therefore supports the further development towards a
registration of the first cytotoxic drug on the large cancer market for
companion animals, as well as serves as a model for human oncology.
About mastocytoma (Skin cancer)
Mastocytoma is a malignant form of cancer, originating from the mastocytom cells
of the skin. The disease is graded I - III depending on the seriousness of the
disease. This form of cancer accounts for approximately 20 % of all malignant
skin tumours in dogs. Today, the most common form of treatment is surgery,
although chemotherapy developed for human use is also used. Unfortunately,
surgery as a treatment of e.g. grade III tumours is mostly ineffective, and
euthanasia is often the only remaining alternative.
About Oasmia
Oasmia Pharmaceutical AB develops second and third generation cancer drugs based
on nanotechnology for human and veterinary use. The broad portfolio is focused
on oncology and contains several promising products in clinical and pre-clinical
phase. Oasmia cooperates with leading universities and other biotech companies
to discover and optimize substances with a favourable safety profile and better
efficacy. The company name was registered in 1999 and is based in Uppsala,
Sweden.
For more information, please contact: Maria Lundén, Head of Public Relations,
Oasmia Pharmaceutical AB.
E-mail: press@oasmia.com Phone: +46 (0) 18 50 54 40. Information is also
available at www.ngm.se and www.oasmia.com
