U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 14, 2014
SUNSHINE BIOPHARMA, INC.
(Exact name of small business issuer as specified in its charter)
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Colorado
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000-52898
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20-5566275
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer ID No.)
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469 Jean-Talon West
3rd Floor
Montreal, Quebec, Canada H3N 1R4
(Address of principal executive offices)
(514) 764-9698
(Issuer’s Telephone Number)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement
On November 14, 2014, we entered into a Manufacturing Services Agreement with Lonza Ltd. and Lonza Sales Ltd., (hereinafter jointly referred to as “Lonza”) of Basel, Switzerland (the “Lonza Agreement”), whereby we engaged Lonza to be the manufacturer of our Adva-27a anticancer drug. Lonza has the expertise and worldwide reputation in the evaluation, development and manufacturing of medical products, including new drugs. Lonza has the assets for the manufacturing of our Adva-27a for clinical supply and commercialization from grams to tons scale. The Lonza Agreement is effective November 10, 2014 and has a term of 5 years, and may be extended or terminated earlier as provided in the Lonza Agreement. Delivery of an initial batch for product validation is expected 18 weeks following receipt of the Purchase Order. The cost is estimated to be 145,550 CHF (approximately $139,700 USD).
Pursuant to the terms of the Lonza Agreement, Lonza will manufacture our drug in accordance with current Good Manufacturing Practices (“cGMP”) in compliance with the regulations applicable in the U.S., Europe and other agreed countries elsewhere around the world relating to the manufacturing of medicinal products for human use. Lonza will build a master drug file for our Adva-27a drug and will have it ready for filing with regulatory authorities as may be required to secure ultimate drug approval. Kilogram level cGMP manufacturing for clinical trials shall commence following completion and testing of the initial product validation batch. Lonza is also responsible for procuring all required raw materials to prepare the batches, at our cost. The Agreement provides for us to maintain one representative of our Company at their facility during the manufacturing process. Quality assurance and control is the responsibility of both Lonza and us during the process.
We have the right to inspect, test and approve all batches to insure compliance with the manufacturing specifications, which is required to be completed within 30 days after release of a batch. In the event of a dispute regarding compliance with the manufacturing specifications, the dispute will be resolved ultimately by independent analysis and testing.
The Lonza Agreement contains customary warranties and disclaimers, confidentiality provisions as well as mutual indemnifications common in agreements of this type.
Item 7.01 Regulation FD Disclosure
Our Press Release relating to the execution of the Lonza Agreement described above is attached as Exhibit 99.5 and is hereby incorporated.
Item 9.01 Financial Statements and Exhibits
(b) Exhibits. The following exhibits are included in this report:
No. Description
99.5 Press Release Announcing Agreement with Lonza
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SUNSHINE BIOPHARMA, INC. |
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Dated: November 19, 2014
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By:
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/s/ Steve N. Slilaty |
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Dr. Steve N. Slilaty |
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Chief Executive Officer |
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3
Exhibit 99.5
For Immediate Release
November 19, 2014
SUNSHINE BIOPHARMA SIGNS AGREEMENT WITH LONZA TO MANUFACTURE ITS LEAD ANTI-CANCER COMPOUND, Adva-27a
Montreal, Quebec, Canada -- (Marketwire) -- Sunshine Biopharma Inc. (OTCQB: “SBFM”), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, announced today an agreement with Lonza, a leading development and manufacturing company, for the manufacture of its anti-cancer drug, Adva-27a. Lonza’s expertise and experience in small molecule development and manufacturing of active pharmaceutical ingredients, was an ideal fit for Sunshine’s Adva-27a. Lonza’s manufacturing capacity ranges from gram quantities for process validation to kilogram amounts for clinical trials and ton quantities for commercialization. Manufacturing will begin at Lonza’s Nansha, China facility with the remaining key steps to be conducted in Lonza’s high containment cytotoxic facility in Visp, Switzerland.
“We are delighted to have a global leader like Lonza as our manufacturing partner,” said Dr. Steve N. Slilaty, President and CEO of Sunshine Biopharma. “We have made significant recent strides in terms of research results showing the effectiveness of our lead compound against cancer cells as well as in our manufacturing and recent fund raising efforts.”
“We are very excited to be working with Sunshine Biopharma on the development of their promising anti-cancer compound”, said James Leresche, Ph.D., Head of Lonza’s Chemical Development Services. “This development project is an example of Lonza’s support and commitment to emerging companies with innovative and potentially life-saving treatments like Adva-27a.”
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma & Biotech and Specialty Ingredients. Further information can be found at www.lonza.com.
About Adva-27a
Adva-27a is Sunshine Biopharma's lead anticancer compound, a Topoisomerase II inhibitor, small molecule that has recently been shown to be effective at killing Multidrug Resistant Breast Cancer cells, Small-Cell Lung Cancer cells, Uterine Sarcoma cells and Pancreatic Cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under U.S. patent number 8,236,935. The Company is planning a Phase I clinical trial of Adva-27a for Pancreatic Cancer in parallel to the Phase I clinical trial of Adva-27a for multidrug resistant Breast Cancer to be conducted at McGill University's Jewish General Hospital in Montreal (Canada).
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.
For Additional Information:
Sunshine Biopharma Media Contacts:
Renmark Financial Communications Inc.
Robert Thaemlitz: rthaemlitz@renmarkfinancial.com
Joshua Ciarrocca: jciarrocca@renmarkfinancial.com
Tel.: (416) 644-2020 or (514) 939-3989
www.renmarkfinacial.com
Sunshine Biopharma Inc. Contacts:
Camille Sebaaly, CFO, Tel.: 514-814-0464, Camille.sebaaly@sunshinebiopharma.com
Lonza Media Contacts:
Colleen Floreck, +1 201 316 9290, colleen.floreck@lonza.com
Constance Ward, +41 61 316 8840, constance.ward@lonza.com