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Ad-hoc: Oasmia Receives FDA Conditional Approval For Its Lead Product Paccal Vet(r)-CA1
Zeit: 28.02.14 11:21
Oasmia Pharmaceutical AB
The issuer is solely responsible for the content of this announcement.
Conditional Approval of Paccal Vet-CA1 Gives Veterinarians Access to Proven
Human Cancer Treatment Paclitaxel
Uppsala, Sweden, 2014-02-28 08:30 CET (GLOBE NEWSWIRE) --
UPPSALA, Sweden, Feb. 28, 2014 - The Swedish pharmaceutical company Oasmia
Pharmaceutical AB (publ) today announced that the U.S. Food and Drug
Administration (FDA) has conditionally approved Paccal Vet(r)-CA1 (paclitaxel for
injection), providing veterinary oncologists with a new treatment option in the
battle with canine mammary carcinoma and squamous cell carcinoma.
Paccal Vet-CA1 is the first veterinary drug to utilize paclitaxel, one of the
most frequently used chemotherapeutics for the treatment of a wide range of
cancers in humans for the past 20 years. Oasmia has signed an agreement with
the global health care company Abbott which gives its Animal Health division
the exclusive worldwide distribution rights to Paccal Vet-CA1, excluding
Russia, Japan and the Commonwealth of Independent States (CIS).
'The conditional approval of Paccal Vet-CA1 is a big step forward for
veterinary cancer treatment,' commented Julian Aleksov, chief executive officer
of Oasmia. 'In addition, it confirms the potential of our unique patented drug
delivery technology XR-17 - a novel derivative of vitamin A that we will be
using in clinical trials with our other compounds for a number of human and
veterinary indications. This also improves the possibilities to secure the
company's long-term financing.'
'Until now, veterinarians in the United States have not been able to safely use
one of the most proven and commonly used chemotherapy agents used to treat
human cancer. With the conditional approval of Paccal Vet-CA1, there is new
hope for our canine patients,' said Dr. Chand Khanna, DVM, PhD, DACVIM, at The
Oncology Service, LLC in Washington D.C., and past president of the American
College of Veterinary Internal Medicine (Oncology). 'Paccal Vet-CA1 is
specifically formulated for use in dogs, giving us an important new weapon in
the fight against canine skin and mammary cancers, which are both significant
clinical problems in veterinary oncology. I am enthusiastic about this new
option and expect to use it widely for pets with these types of cancer.'
'Pets are living longer and owners increasingly desire a 'human level of care'
for serious and chronic conditions,' said Andrea Wainer, divisional vice
president and general manager, Animal Health, Abbott. 'With the FDA conditional
approval of Paccal Vet-CA1, we are able to offer veterinarians and pet owners a
trusted cancer therapy used to treat millions of people each year.'
Cancer accounts for nearly 50 percent of all deaths in dogs 10 years of age or
older. It is the leading cause of canine disease-related deaths, with up to
three million new cases diagnosed annually worldwide.
Canine squamous cell carcinoma, a type of skin cancer, is a malignant tumor of
epidermal cells which is often developed in the oral and nasal cavities and on
the paws. Light-skinned and short-haired dogs that spend a long time in the
sunshine have a higher risk of squamous cell carcinoma.
Mammary carcinoma is the most common tumor in female dogs that have not been
spayed, affecting one out of every four. Overweight females and those fed a
diet high in fat are at the greatest risk for developing mammary cancer.
For more information, please contact:
Mikael Widell, Vice President Communications
Mobile: +46 70 311 99 60
Notes to editors:
About Paccal Vet(r)-CA1 (paclitaxel for injection)
Paccal Vet-CA1 is a paclitaxel cancer treatment developed especially for dogs.
It is a novel formulation containing paclitaxel, one of the most frequently
used human chemotherapeutic agents. Paccal Vet-CA1 is a novel nanoparticle
formulation composed of Oasmia Pharmaceutical's patented excipient XR-17 that
can be used to improve the solubility of substances like paclitaxel in suitable
aqueous solvents. Two prospective, blinded, randomized trials to obtain full
regulatory approvals in the U.S. and Europe are soon to be initiated.
In the United States, Paccal Vet-CA1 is indicated for the treatment of
resectable and non-resectable squamous cell carcinoma (a type of skin cancer)
in dogs that have not received previous chemotherapy or radiotherapy, and for
the treatment of non-resectable stage III, IV or V mammary carcinoma (mammary
cancer) in dogs that have not received previous chemotherapy or radiotherapy.
These indications are conditionally approved pending a full demonstration of
Paccal Vet (paclitaxel for injection) Important Risk Information
Contraindications, warnings and precautions: Do not use in dogs that have
neutropenia (< 2000 cells/muL) or that have concurrent serious infection or in
dogs that are pregnant, lactating or intended for breeding. Extravasation
during administration can cause focal tissue necrosis and should be avoided.
Persons sensitive to retinoids should avoid contact with the drug. Hospital
staff and clients should use standard measures for handling cytotoxic drugs and
should avoid contact with the drug and the patient's excretions for the
recommended time period. The client should be educated in safe handling of
their treated dog's excretions. More detailed preparation and administration
information including special instructions for avoiding human exposure to waste
products are supplied in the package insert and the client information sheet.
Adverse reactions: Paclitaxel can cause severe, transient bone marrow
suppression within four to seven days of administration and can cause adverse
gastrointestinal reactions due to transient gastrointestinal mucosal cell
toxicity. In a field study, all the dogs treated (n=168) experienced at least
one adverse reaction. Paclitaxel has a low margin of safety, but adverse
reactions were manageable with appropriate patient monitoring and supportive
care. The most frequent adverse reactions were: neutropenia, vomiting,
anorexia, diarrhea, and lethargy. Less frequent but still significant adverse
reactions included: alopecia, dehydration, dermatitis, hepatopathy, edema,
pyrexia, and lameness. Other, less frequent adverse reactions included: urine
abnormality, pruritus, erythema, anemia, loss of body condition, cutaneous
ulceration, thrombocytopenia, neoplasia, polydipsia, conjunctivitis, and death
See package insertfor full prescribing information.
This is not a complete list of the Important Safety Information for Paccal Vet-
CA1. For additional important safety information, please click for the Full
About conditional approval
A conditionally approved drug may be marketed for up to five years, subject to
annual renewals, while collecting substantial evidence of effectiveness.
Because full effectiveness of a conditionally approved drug has yet to be
demonstrated and only a reasonable expectation of effectiveness has been
demonstrated for the specific indication(s), use of the drug in an extra-label
manner is not allowed. Veterinarians can only use the drug for its approved
In contrast, a fully-approved drug has already demonstrated substantial
evidence of effectiveness and safety prior to marketing; therefore, there are
no limitations on marketing and under certain conditions, a fully approved drug
may be used in an extra-label manner.
About Oasmia Pharmaceutical AB
(NASDAQ OMX: OASM) (General Standard of Frankfurt Stock Exchange: OMAX, ISIN
SE0000722365) Oasmia Pharmaceutical AB develops new generations of drugs within
human and veterinary oncology. The company's product development aims to create
and manufacture novel nanoparticle formulations and drug-delivery systems based
on well-established cytostatics, which, in comparison with current
alternatives, show improved properties, reduced side effects, and expanded
applications. Oasmia's product development is based on its proprietary in-house
research and company patents. The company's common stock is listed on NASDAQ
OMX Stockholm and the Frankfurt Stock Exchange.www.oasmia.com
Mikael Widell, Vice President Communications Mobile: +46 70 311 99 60
Click on, or paste the following link into your web browser, to view the associated
News Source: NASDAQ OMX
Company: Oasmia Pharmaceutical AB
End of Announcement
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