Farnham, UK, 15 October 2010: Biocompatibles (LSE:BII), the medical technology company, today provides the following update the status of the Novabel1 Product.
On 26th June, the company announced the decision of its licencee and marketing partner, Merz Pharmaceuticals GmbH, to write a letter to its customers and temporarily suspend shipments of Novabel.
The letter reported on “adverse reactions in a few patients treated with Novabel” and committed to the development of “an effective treatment to quickly resolve these events”. Merz announced that it would “temporarily suspend all sales….of Novabel pending the availability of [this treatment].” The two companies intended that shipments to physicians would resume “in the near future”.
Progress has been made with a potential reversing agent and Merz has indicated that it remains committed to the re-introduction of Novabel into EU markets and to the initiation of a US regulatory programme.
However, no date has yet been established for the re-introduction of Novabel and Biocompatibles management has therefore taken the decision not to budget any production or sales of the product to Merz in 2011. The business plan had included sales to Merz of around £3m in 2011.
Intensive work continues on the programme with the active involvement of both companies. Further updates will be provided as more material details become available.
The Company will review the carrying value of the assets supporting the Novabel programme at the end of the current financial year. Depending on Merz’s plans and timescales an impairment of these assets may be required and, to the extent it affects the current financial year, will impact Net Profit.
Crispin Simon, Chief Executive commented “We believe, and so do Merz, that Novabel will again become a popular and valuable product”.
1 Novabel is a registered trademark of Merz Pharmaceuticals GmbH, Biocompatibles’ licencee and marketing partner.
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
|+44 (0) 1252 732706|
|Anna Keeble||+44 (0) 7879 818876|
Dealing Disclosure Requirements
Following the announcement made on Monday, 20 September 2010 that the Company is in an offer period for the purposes of the Takeover Code, the Company is required to restate the following:
Under Rule 8.3(a) of the Code, any person who is interested in 1% or more of any class of relevant securities of an offeree company or of any paper offeror (being any offeror other than an offeror in respect of which it has been announced that its offer is, or is likely to be, solely in cash) must make an Opening Position Disclosure following the commencement of the offer period and, if later, following the announcement in which any paper offeror is first identified. An Opening Position Disclosure must contain details of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any paper offeror(s). An Opening Position Disclosure by a person to whom Rule 8.3(a) applies must be made by no later than 3.30 pm (London time) on the 10th business day following the commencement of the offer period and, if appropriate, by no later than 3.30 pm (London time) on the 10th business day following the announcement in which any paper offeror is first identified. Relevant persons who deal in the relevant securities of the offeree company or of a paper offeror prior to the deadline for making an Opening Position Disclosure must instead make a Dealing Disclosure.
Under Rule 8.3(b) of the Code, any person who is, or becomes, interested in 1% or more of any class of relevant securities of the offeree company or of any paper offeror must make a Dealing Disclosure if the person deals in any relevant securities of the offeree company or of any paper offeror. A Dealing Disclosure must contain details of the dealing concerned and of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any paper offeror, save to the extent that these details have previously been disclosed under Rule 8. A Dealing Disclosure by a person to whom Rule 8.3(b) applies must be made by no later than 3.30 pm (London time) on the business day following the date of the relevant dealing. If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire or control an interest in relevant securities of an offeree company or a paper offeror, they will be deemed to be a single person for the purpose of Rule 8.3.
Opening Position Disclosures must also be made by the offeree company and by any offeror and Dealing Disclosures must also be made by the offeree company, by any offeror and by any persons acting in concert with any of them (see Rules 8.1, 8.2 and 8.4).
Details of the offeree and offeror companies in respect of whose relevant securities Opening Position Disclosures and Dealing Disclosures must be made can be found in the Disclosure Table on the Takeover Panel’s website at www.thetakeoverpanel.org.uk, including details of the number of relevant securities in issue, when the offer period commenced and when any offeror was first identified. If you are in any doubt as to whether you are required to make an Opening Position Disclosure or a Dealing Disclosure, you should contact the Panel’s Market Surveillance Unit on +44 (0)20 7638 0129.
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead Products which are used in more than 40 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
This news release contains forward-looking statements that reflect Biocompatibles’ current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of Biocompatibles’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.