Hikma Pharmaceuticals Regulatory News (HIK)

Vectura Group plc

VR315 US

ANDA for Generic Advair Diskus® accepted for filing by FDA and milestone payment

Chippenham, UK - 8 April 2016: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms that our partner on VR315 US, Hikma Pharmaceuticals PLC (through its wholly-owned subsidiary, West-Ward Pharmaceuticals) has confirmed its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The FDA provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, with a GDUFA goal date of 10 May, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura's proprietary dry powder inhaler and formulation technology. The acceptance triggers a cash milestone payment to Vectura of $10 million.

Vectura is eligible to receive a further milestone payment of $11m upon approval by the FDA. In addition, Vectura will receive a royalty from all sales of VR315 in the US. 

James Ward-Lilley CEO, commented:

"The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme. With our partner, Hikma, we have worked closely with FDA to ensure the quality of the ANDA submission. Our interactions with FDA have helped clarify the requirements for the development of a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus. We believe that the strong data package submitted will facilitate the approval of VR315 and gives us confidence that Hikma can be among the first companies to launch this product in the US. We look forward to working with our partner through the FDA approval process to bring this very important product for patients and which, upon successful launch, will be a major value driver for Vectura."

ADVAIR and ADVAIR DISKUS are registered trademarks of Glaxo Group Limited.

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About VR315

This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura's proprietary dry powder inhaler and formulation technology.

About Hikma

Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: "Injectables", "Branded" and "Generics", based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

About Vectura

Vectura is a leading independent inhaled device, formulation, development and specialist commercial

business focusing on the development of pharmaceutical therapies for the treatment of airways diseases.

Vectura was established in 1997 to identify and develop opportunities in drug formulation and delivery.

Vectura was listed on the London Stock Exchange in 2007 and is a member of the FTSE 250 index. Vectura's main locations are in Chippenham and Cambridge, in the UK, and Munich, in Germany.

Vectura's strong revenue growth is driven by an increasing amount and range of royalties from marketed products and significant milestone achievements. Vectura's diversified and rapidly growing revenue base from the development and commercialisation of its partnered products underpins the cash flow to develop its pipeline and maintain investment in technology.

Vectura has established development collaborations, joint ventures and licence agreements with several global pharmaceutical and biotechnology companies, including Hikma (through its wholly-owned subsidiary, West-Ward Pharmaceuticals), Novartis, Sandoz, Baxter, GSK, UCB, Ablynx, Grifols, Janssen and Tianjin KingYork Group Company. Vectura has committed pipeline programmes combining novel and known treatments and is eligible for potential future milestone payments of more than £90 million through to the financial year 2022. Unique proprietary DPI and smart nebulisation technologies provide Vectura with a base for further collaboration agreements with new and existing partners.

For further information, please visit Vectura's website at www.vectura.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.