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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

28.02.2014 08:30

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

E-mail: mikael.widell@oasmia.com

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

and euthanasia.

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

Prescribing Information.

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

E-mail: mikael.widell@oasmia.com

Click on, or paste the following link into your web browser, to view the associated




News Source: NASDAQ OMX


Language: English

Company: Oasmia Pharmaceutical AB






ISIN: SE0000722365


End of Announcement

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