Shire to Attain Enhanced CINRYZE® Manufacturing Flexibility and Capacity
The company enters into new agreement with Sanquin
LEXINGTON, Massachusetts, August 25, 2015 /PRNewswire/ --Shire plc (LSE: SHP, NASDAQ: SHPG) announced today it has entered into an agreement with Sanquin Blood Supply, the manufacturer of CINRYZE® (C1 esterase inhibitor [human]), providing Shire access to its manufacturing technology and allowing Shire to source additional manufacturers to meet the growing demand for CINRYZE.
"We wanted the freedom to operate and expand in a way that makes strategic sense for our business," said Flemming Ornskov, M.D., CEO, Shire. "When Shire acquired ViroPharma in January 2014, we inherited an arrangement under which Sanquin was the exclusive manufacturer for CINRYZE. We're pleased that Sanquin was open to expanding our partnership and agreeing to support us as we increase production options for this important therapy."
The specific terms of the agreement are confidential, but involve payments to Sanquin on achievement of certain milestones, including a successful technical transfer to a second source manufacturer. Sanquin will continue to serve as a key partner with Shire to increase global supply of CINRYZE.
CINRYZE is used for the prophylactic treatment of Hereditary Angioedema (HAE). HAE is a rare genetic disease characterized by recurrent sudden attacks of swelling of the skin or the mucous membranes which can be disfiguring, painful and potentially life-threatening in the case of laryngeal attacks. One of Shire's top selling products, CINRYZE generated $503 million in sales in 2014.
CINRYZE® (C1 esterase inhibitor [human]) is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE).
Important Safety Information
You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.
Tell your healthcare provider about all of your medical conditions, including if you:
- have an indwelling catheter/access device in one of your veins.
- have a history of blood clots, heart disease, or stroke.
- are taking birth control pills or androgens.
- are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.
Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- difficulty breathing
- chest tightness
- turning blue (look at lips and gums)
- fast heartbeat
- swelling of the face
Serious blood clots may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- pain and/or swelling of an arm or leg with warmth over the affected area
- discoloration of an arm or leg
- unexplained shortness of breath
- chest pain or discomfort that worsens on deep breathing
- unexplained rapid heart rate
- numbness or weakness on one side of the body
Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common side effects seen with CINRYZE were headache, nausea, rash, and vomiting. These are not all the possible side effects of CINRYZE. Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report side effects to Shire Medical Information at 1-866-888-0660.
Please see Full Prescribing Information.
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts 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, that:
- Shire's products may not be a 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 Shire's products may affect future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of the Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with 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;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products 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 Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire's revenues, financial conditions or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire'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 and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire's financial condition and results of operations; and other risks and uncertainties detailed from time to time in Shire's filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.