Welcome to your Monday Biotech Deal Review for November 18, 2013! This week saw significant activity in the biotech space, so follow the link to see the full week’s worth of major biotech stories!
Calyx Bio-Ventures Inc. (TSX-V: CYX) (the “Company”) announced that the TSX Venture Exchange (the “Exchange”) has approved the extension of the expiry date of 6,666,832 common share purchase warrants (the “Warrants”) issued to placees as part of a private placement financing which closed in two tranches on November 9, 2012 and December 13, 2012. The expiry dates of the Warrants have been extended for a period of six months. The expiry date of the Warrants issued on November 9, 2012 has been extended to May 9, 2014, and the expiry date of the Warrants issued on December 13, 2012 has been extended to June 13, 2014. The Exchange did not approve the extension of Warrants issued to agents and finders, and all such Warrants have expired or will expire according to their original terms. All other terms of the Warrants remain the same
ZoomMed Inc. (TSX-V: ZMD) (the “Company”) announced it has signed a term sheet with regards to a four million dollar ($4,000,000) non-convertible debenture financing, subject to due diligence. Subject to the approval of the TSX Venture Exchange and the regulatory authorities, ZoomMed will issue to MSU Securities Law Professional Corporation (“MSU”) five hundred and eight thousand seven hundred and eighty-six (508,786) common shares of the Company at a deemed price of five cents ($0.05) per common share, as compensation for legal due diligence services rendered within the scope of the financing. ZoomMed deals at arm’s length with MSU.
Pyng Medical Corp. (TSX-V: PYT) (the “Company”) announced that it has issued a Promissory Note dated October 1, 2013 (the “Note”) and related General Security Agreement dated October 31, 2013 with its strategic manufacturing partner (the “Strategic Partner”). The Note has a principal sum of US$1,000,000, plus interest of 12% per annum, and is payable in blended monthly principal and interest payments up to and including September 30, 2015. The Note represents payment of various accounts payable, past due interest, and some prepaid costs related to new products under development. A security interest was granted to the Strategic Partner by way of a General Security Agreement over all the assets of Pyng, but subordinate to an existing first senior position held by the holders of Pyng’s existing Convertible Debentures outstanding in the amount of CDN$545,000, which mature on August 10, 2014. If the Convertible Debentures are reissued, this first senior position will stay in effect to a maximum of CDN$545,000.
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that it has priced its previously announced offering of 5.625% senior unsecured notes due 2021 (the “Notes”). The Company increased the offering to $900 million from $850 million aggregate principal amount of the Notes. The offering is expected to close on or about December 2, 2013. The net proceeds of the offering is expected to be used to finance the redemption of all of the Company’s wholly-owned subsidiary’s, Valeant Pharmaceuticals International’s, outstanding 6.50% Senior Notes due 2016, as well as to pay fees and expenses related to the foregoing. Concurrently with the pricing of this offering, Valeant Pharmaceuticals International has irrevocably called for redemption $450 million aggregate principal amount of its 6.50% Senior Notes due 2016. On the closing date of this offering, Valeant Pharmaceuticals International intends to irrevocably call for redemption the remaining $465.5 million aggregate principal amount of its 6.50% Senior Notes due 2016 and use the remaining net proceeds from this offering, together with approximately $50 million of either cash on hand or from borrowings under the Company’s revolving credit facility, or a combination thereof, to pay the redemption price of the notes called.
iCo Therapeutics Inc. (TSX-V: ICO) announced that subsequent to the quarter ended September 30th, 2013, 3,207,000 warrants from the November 1st 2011 financing which were exercisable at $0.30 and due on November 1, 2013 (the “Warrants”), have been exercised for total proceeds of approximately $962,000. Of the total 5,767,000 warrants issued during the financing in November 2011, 4,834,000 (84%) were exercised for total gross proceeds of $1,450,200. No Warrants from the financing remain outstanding.
Atrium Innovations Inc. (TSX: ATB) (the “Company”) announced that it has filed with the Toronto Stock Exchange (“TSX”), and the TSX has accepted, a Notice of Intention to make a Normal Course Issuer Bid. Under its normal course issuer bid, Atrium intends to purchase up to 1,095,474 of its common shares, representing approximately 3.5% of the 31,299,261 common shares issued and outstanding as of October 31, 2013. The average daily trading volume for the 6-month period preceding October 31, 2013 represents 36,203 common shares. In accordance with the TSX requirements, a maximum daily purchase of the greater of 25% of this average or 1,000 shares may be made, which represents a total of 9,050 common shares. Purchases will be made on the open market by Atrium through the facilities of the TSX. The purchases may commence on November 15, 2013 and will terminate on November 14, 2014, or on such earlier date as Atrium will have completed its purchases pursuant to the Notice of Intention to make a Normal Course Issuer Bid filed with the TSX. Atrium will cancel any common shares purchased pursuant to the normal course issuer bid. Atrium will pay the market price of common shares on the TSX at the time of purchase and no purchases of common shares will be made other than open-market purchases.
Commercial & Other Agreements
Medifocus, Inc. (TSX-V: MFS) (the Company) announced that it has entered into a joint venture agreement with Ideal Concept Group, Ltd. (ICG). Under the terms of the joint venture agreement, ICG and Medifocus will own 60% and 40% of the Joint Venture (JV), respectively. The initial focus of the JV is to assist Medifocus in obtaining commercial approval for the Company’s Prolieve® Thermodilatation System from the China Food and Drug Administration (CFDA) to allow the marketing and sales of Prolieve® as a treatment for benign prostatic hyperplasia (BPH) in China. Following the CFDA approval, the JV intends to seek distributors to market and sell Prolieve® in Greater China and other countries in Asia. In parallel, the JV will identify and select GMP compliant manufacturers for the Prolieve® system and treatment disposables to reduce costs and broaden supply channels.
Axxess Pharma Inc. (PINKSHEETS: AXXE) announced it has signed an agreement with Vortex Traffic to initiate and grow its online sales beginning with its TapouT brand of products. Since 2007 Vortex has produced over $140 million in global sales for its clients, primarily in the health and beauty industry.
MedMira Inc., (TSX-V: MIR) announced a collaborative research agreement with the National Research Council of Canada (NRC). MedMira will receive funding support towards this research from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). MedMira and NRC will work together over a 10 month period on two key areas that will expand the capabilities of MedMira’s rapid diagnostic technology platform.
Theratechnologies Inc. (TSX:TH) announced that it has been informed by Jubilant HollisterStier (Jubilant), the third-party contract manufacturer for tesamorelin, that a strike has been initiated by employees working at its manufacturing site in Montreal, Canada. Despite this labour action, the Company was informed by Jubilant that the shipment of tesamorelin was still expected to resume by mid-December. Theratechnologies is currently working with Jubilant management to minimize the consequences of this event on the future manufacturing and shipment of tesamorelin and to minimize inconvenience to patients.
Paladin Labs Inc. (TSX: PLB) announced that the U.S. Food and Drug Administration (FDA) has notified Paladin that it is extending the Prescription Drug User Fee Act (PDUFA) goal date for its new drug application (NDA) for Impavido® (miltefosine) for the treatment of cutaneous, mucosal, and visceral leishmaniasis from December 19, 2013 to March 19, 2014. During the course of recent discussions with the FDA, Paladin submitted revisions regarding chemistry, manufacturing and control (CMC) details and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date to March 19, 2014. The FDA has not requested at this time any additional clinical studies prior to the revised PDUFA action date.
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, has received notice that the New Drug Application for Luzu® (luliconazole) Cream, 1% has been approved by the United States Food and Drug Administration (FDA). Luzu® Cream, 1% is indicated for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. These are very common skin diseases caused predominantly by dermatophyte fungi.
Neovasc Inc. (TSX-V: NVC) announced that the first patent covering the company’s innovative Tiara™ transcatheter mitral valve replacement technology has been issued by the US Patent and Trademark Office. The new patent protects key aspects of the Tiara mitral valve prosthesis. It is the first patent to issue from a portfolio of US and international patent applications Neovasc has filed aimed at establishing an extensive intellectual property estate covering the entire Tiara program, including the prosthesis, delivery system, associated accessories and methods of use. Tiara is in development for the treatment of severe mitral valve disease. US Patent No. 8,579,964, “Transcatheter Mitral Valve Prosthesis,” was issued by the US Patent and Trademark Office on November 12, 2013.