ADVATE Now Available in India for the Treatment and Prophylaxis of Hemophilia A

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  • ADVATE is the world's most widely used FVIII treatment with 13 years of proven real-world patient experience
  • World’s first third generation clotting factor eliminates the risk of transmission of blood-borne pathogens
  • Every bleed matters – In India today, there are about 16,000 patients registered with Hemophilia but the actual number could be 7 times more due to low awareness, diagnosis and treatment

[New Delhi, India] – [July 13, 2016] – Shire plc (LSE: SHP, NASDAQ: SHPG) announces today the launch of ADVATE (Octocog alfa - Recombinant Coagulation Factor VIII) in India for the treatment and prophylaxis of bleeding in patients with hemophilia A. ADVATE, which came to Shire as part of the recent Baxalta combination, was approved in the U.S. since July 2003 and has a proven safety and efficacy profile with over 13 years of real-world patient experience data. It is the world's most widely used FVIII treatment to date. Marketing Authorization Holder: Baxalta Biosciences India Pvt. Ltd. (now part of Shire), 6th Floor, Tower-C, Building No.8, DLF Cyber City, DLF Phase-II, Gurgaon-122 002, Haryana, India.

Shire has been part of the Hemophilia community for over 60 years. We are committed to the advancement of Hemophilia treatments and elevating the standard of care for hemophilia patients in India because we know that many of them out there are not diagnosed, let alone treated. Striving toward a goal of zero bleeds, we are able to bring innovative third generation treatments like ADVATE to patients in India and help them achieve better outcomes in managing their bleeding conditions,” said Vineet Singhal, Country Head, Baxalta Biosciences India Pvt. Ltd.

ADVATE is the world’s first third generation recombinant factor VIII – a full-length molecule that uses the complete gene, similar to the factor VIII that occurs naturally in the body, and was first of its kind to be developed without the addition of any human or animal-derived protein in the cell culture process, purification or final formulation. The treatment of this rare genetic bleeding disease, Hemophilia, also greatly reduce the risk of transmission of blood-borne pathogens, and relies on clotting factors concentrates of high quality.

Clotting factor concentrates can be made in two different ways:

  • Plasma-derived clotting factors - prepared from the plasma of donated human blood.
  • Recombinant clotting factors - the first generation of recombinant products use animal products in the culture medium and had human albumin (a human blood product) added as a stabilizer. Second generation products use animal-derived materials in the culture medium but do not have added albumin and instead, use sucrose or other non-human derived material as a stabilizer. Third generation products are produced without the addition of any human or animal-derived protein in the cell culture process, purification or final formulation.

With the introduction of the third generation clotting factors which have no albumin present at any stage of their preparation, patients in India now have access to a safer and more reliable therapy option. ADVATE has a 24 months shelf life and allows 6 months storage at room temperature within this shelf life period. In addition, ADVATE has been clinically shown to reduce the number of bleeding episodes in adults and children (0-16 years) for up to 98 percent when used regularly (prophylaxis).

About Hemophilia A

Hemophilia A is a challenging chronic disease affecting 1 in 10.000 male births with no difference in geography and races. If untreated, people with haemophilia will suffer from recurrent bleeding causing pains which lead to disability and even young death. Today, The World Federation of Hemophilia estimates that the disease affects more than 400,000 people worldwide, with an estimated 75 percent of them being undiagnosed and untreated or undertreated globally.

According to the Hemophilia Federation of India, only 16,000 or 15 percent of the total Hemophilia population has been currently identified in India and the rest lay undiagnosed – which could be ranging 7 times more than the current registered patients. For people with hemophilia, reducing their bleeding episodes (measured by annual bleed rate (ABR)) may have a significant improvement on long-term outcomes and quality of life.

About ADVATE

ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • Control and prevention of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

ADVATE is not indicated for the treatment of von Willebrand disease.

ADVATE has a demonstrated efficacy and safety profile for the treatment of hemophilia A. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is virtually eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.

ADVATE is the world's most prescribed FVIII treatment, currently approved in 68 countries worldwide.

Please see full prescribing information for ADVATE at: www.advate.com /assets/pdf/advate_iri_pi.pdf.

For further information please contact:

Ritika Kapoor, Media Contact
ritika.kapoor@shire.com
+91 9887 389 982

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

www.shire.com

Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

  • disruption from the acquisition and integration of Baxalta Incorporated (“Baxalta”) may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;
  • the company may not achieve some or all of the anticipated benefits of Baxalta’s spin-off from Baxter International, Inc. (“Baxter”) and the acquisition may have an adverse impact on Baxalta’s existing arrangements with Baxter, including those related to transition, manufacturing and supply services and tax matters;
  • the failure to achieve the strategic objectives with respect to the acquisition of Baxalta may adversely affect the company’s financial condition and results of operations;
  • products and product candidates may not achieve commercial success;
  • product sales from ADDERALL XR and INTUNIV are subject to generic competition;
  • the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the company’s products may affect future revenues, financial condition and results of operations, particularly if there is pressure on pricing of products to treat rare diseases;
  • supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors; regulatory actions associated with product approvals or changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
  • the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
  • the actions of certain customers could affect the company’s ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the company’s revenues, financial condition or results of operations;
  • investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the company’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
  • adverse outcomes in legal matters, tax audits and other disputes, including the company’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the company’s revenues, financial condition or results of operations;
  • Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect the company’s ability to attract and/or retain the highly skilled personnel needed to meet its strategic objectives;
  • failure to achieve the strategic objectives with respect to Shire’s acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. (“Dyax”) may adversely affect the company’s financial condition and results of operations;
  • the company is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on the company’s revenues, financial condition or results of operations;
  • the company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners;
  • difficulties in integrating Dyax or Baxalta into Shire may lead to the company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and other risks and uncertainties detailed from time to time in Shire’s, Dyax’s or Baxalta’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s and Baxalta’s Annual Reports on Form 10-K for the year ended December 31, 2015.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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