Sandoz has signed a definitive agreement to acquire Oriel Therapeutics, a privately held US pharmaceuticals company, gaining exclusive rights to a portfolio of generic drug candidates and related technologies targeting medicines in the inhalable respiratory drug market. Terms of the deal were not disclosed.
Oriel focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD).
The acquisition provides Sandoz with three promising development projects targeting leading medicines in this field.
Regulatory approvals of these medicines, if achieved, would enable Sandoz to increase access to affordable, high-quality therapeutic alternatives for these increasingly prevalent diseases. Details of Oriel's development programs, including anticipated timing of future regulatory submissions, are not disclosed for competitive reasons.
"Oriel is a strong strategic fit with Sandoz and the acquisition is expected to support our strategy of increasing the number of differentiated, higher-value products in our development pipeline," said Jeff George, Division Head Sandoz. "One of our strategic objectives is to offer fully substitutable generic versions of key branded medicines, including respiratory medicines. This is a key area of focus that complements our global leadership position in biosimilars and complex injectables."
The acquisition of Oriel, which will be integrated as a separate development unit within Sandoz, also offers Sandoz access to its novel FreePath(TM) drug delivery technology. This has the potential to address some of the hurdles facing regulatory approval of generic inhaled medicines in the US. Oriel has also developed the proprietary Solis(TM) disposable dry powder inhaler based on the FreePath(TM) delivery technology.
According to industry estimates approximately 50% of the current USD 32 billion global market segment[1] for asthma and COPD medicines is expected to lose patent protection by the end of 2016.[2] Key patents due to expire over this period in one or more major countries or regions include Advair®/Seretide®[3], Symbicort®[4], Singulair®[5] and Spiriva®[6]. The asthma and COPD market segment is projected to grow significantly faster than the pharmaceutical market, driven by factors including a significant level of under-diagnosis.
The acquisition will enable Sandoz to leverage both its existing range of in-market products and its extensive in-house expertise. In 2009, Sandoz invested more than USD 60 million in a new 10 000 m2 facility at its global respiratory Center of Excellence in Rudolstadt, Germany, which has validated full-scale manufacturing capacities for both DPI and MDI inhalers.
In 2009, Sandoz broadened its existing respiratory portfolio by launching generic salbutamol in several European countries, as the first EU-wide approved generic inhalable product under new EU regulatory guidelines. In addition to its in-house expertise, Sandoz has collaborations with other companies as well as with Novartis Pharmaceuticals Division, which maximize its access to quality generic inhalable device mechanisms. Novartis Pharmaceuticals has a complementary portfolio of high-quality patent-protected respiratory medicines as well as an extensive development pipeline.
Terms of agreement
Sandoz has reached a definitive agreement to fully acquire Oriel Therapeutics, with terms of the deal not disclosed. Oriel's owners are eligible for additional payments, which are contingent upon the achievement of various milestones related to the technical development of these projects as well as regulatory approvals and market launches. Oriel's owners would also be eligible for sales royalties. This transaction is subject to customary closing conditions.
About Oriel
Oriel Therapeutics is a specialty pharmaceutical company developing and commercializing products to improve respiratory care. Combining an experienced product development team and a growing portfolio of innovative drug delivery technologies, Oriel is focused on delivering compelling patient options for the treatment of asthma and COPD. Oriel's investors include New Leaf Venture Partners, Thomas, McNerney & Partners, HealthCare Ventures and CHL Medical Partners.
About Sandoz
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of about 1000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and Eon Labs (US), and EBEWE Pharma (Austria). In 2009, Sandoz employed around 23,000 people worldwide and achieved net sales of USD 7.5 billion.
[1] IMS 2009
[2] Publicly available information including IMS and DataMonitor
[3] Advair®/Seretide® are registered trademarks of GlaxoSmithKline
[4] Symbicort® is a registered trademark of AstraZeneca
[5]Singulair® is a registered trademark of Merck
[6] Spiriva® is a registered trademark of Boehringer Ingelheim