Prothena Corporation plc
Prothena Corp plc (Form: 8-K, Received: 12/11/2013 16:08:09)


UNITED STATES
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): December 11, 2013
_______________________________________________________
Prothena Corporation plc
(Exact Name of Registrant as Specified in its Charter)
_______________________________________________________
Ireland
(State or Other Jurisdiction of Incorporation)
 
 
 
001-35676
 
98-1111119
(Commission
File Number)
 
(IRS Employer
Identification No.)
650 Gateway Boulevard
South San Francisco, California 94080
(Address of Principal Executive Offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 837-8550
______________________________________
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 ( see General Instruction A.2. below):
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 December 11, 2013, Neotope Biosciences Limited (“ Neotope ”) and Prothena Biosciences Inc (“ PBI ”, and together with Neotope, “ Prothena ”), each a wholly owned subsidiary of Prothena Corporation plc, entered into a License, Development, and Commercialization Agreement (the “ License Agreement ”) with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “ Roche ”) to develop and commercialize certain antibodies that target alpha-synuclein, including PRX002, Prothena’s monoclonal antibody for the treatment of Parkinson’s disease (collectively, the “ Licensed Products ”). The effectiveness of the License Agreement is subject to the completion of customary regulatory clearances, including expiration of the applicable Hart-Scott-Rodino (“ HSR ”) waiting period.

Upon the effectiveness of the License Agreement, Prothena will grant to Roche an exclusive, worldwide license to develop, make, have made, use, sell, offer to sell, import, and export the Licensed Products. Prothena will retain certain rights to conduct development of the Licensed Products and an option to co-promote PRX002. Thereafter, during the term of the License Agreement, Prothena and Roche will work exclusively with each other to research and develop antibody products targeting alpha-synuclein. Roche will provide funding for a research collaboration between the parties focused on optimizing early stage antibodies targeting alpha-synuclein, potentially including incorporation of Roche’s proprietary Brain Shuttle™ technology to increase delivery of therapeutic antibodies to the brain.

After the filing of the investigational new drug application with the U.S. Food and Drug Administration for PRX002 by Prothena, Roche will be primarily responsible for developing, obtaining and maintaining regulatory approval for, and commercializing the Licensed Products. Roche will also become responsible for the clinical and commercial manufacture and supply of the Licensed Products within a defined time period following the effective date of the License Agreement.

The License Agreement provides that Roche will pay Prothena an upfront payment and a near-term clinical milestone payment totaling $45.0 million. For PRX002, Roche is also obligated to pay:

up to $380.0 million upon the achievement of development, regulatory and first commercial sale milestones;
up to an additional $175.0 million in ex-U.S. commercial sales milestones; and
tiered, high single-digit to high double-digit royalties in the teens on ex-U.S. annual net sales, subject to certain adjustments.

In the United States, the parties will share all development and commercialization costs, as well as profits, all of which will be allocated 70% to Roche and 30% to Prothena, for PRX002 in the Parkinson’s disease indication, as well as any other Licensed Products and/or indications for which Prothena opts in to participate in co-development and co-funding. Prothena may opt out of the co-development and cost and profit sharing on any co-developed Licensed Products and instead receive U.S. commercial sales milestones totaling up to $155.0 million and tiered, single-digit to high double-digit royalties in the teens based on U.S. annual net sales, subject to certain adjustments, with respect to the applicable Licensed Product. In addition, Prothena has an option under the License Agreement to co-promote PRX002 in the United States in the Parkinson’s disease indication. If Prothena exercises such option, it may also elect to co-promote additional Licensed Products in the United States approved for Parkinson’s disease. Outside the United States, Roche will have responsibility for developing and commercializing the Licensed Products.

The License Agreement continues on a country-by-country basis until the expiration of all payment obligations under the License Agreement. The License Agreement may also be terminated (i) by Roche at will after the first anniversary of the effective date of the License Agreement, either in its entirety or on a Licensed Product-by-Licensed Product basis, upon 90 days’ prior written notice to Prothena prior to first commercial sale and 180 days’ prior written notice to Prothena after first commercial sale, (ii) by either party, either in its entirety or on a Licensed Product-by-Licensed Product or region-by-region basis, upon written notice in connection with a material breach uncured 90 days after initial written notice, and (iii) by either party, in its entirety, upon insolvency of the other party. The License Agreement may be terminated by either party on a patent-by-patent and country-by-country basis if the other party challenges a given patent in a given country. Prothena’s rights to co-develop Licensed Products under the License

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Agreement will terminate if Prothena commences certain studies for certain types of competitive products. Prothena’s rights to co-promote Licensed Products under the License Agreement will terminate if Prothena commences a Phase 3 study for such competitive products.

The License Agreement cannot be assigned by either party without the prior written consent of the other party, except to an affiliate of such party or in the event of a merger or acquisition of such party, subject to certain conditions. The License Agreement also includes customary provisions regarding, among other things, confidentiality, intellectual property ownership, patent prosecution, enforcement and defense, representations and warranties, indemnification, insurance, and arbitration and dispute resolution.

The foregoing description of the terms of the License Agreement does not purport to be a complete description and is qualified in its entirety by reference to the full text of the License Agreement, which Prothena intends to file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2013.

Item 7.01 Regulation FD

On December 11, 2013, Prothena issued a press release announcing the License Agreement with Roche, a copy of which is furnished as Exhibit 99.1 to this Report and incorporated by reference.

The foregoing information in Item 7.01 of this Current Report on Form 8-K, together with the press release attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to Item 7.01 of this Current Report on Form 8-K.

Forward-Looking Statements

The disclosures contained or incorporated by reference in Item 1.01 and Item 7.01 contain forward-looking statements regarding the License Agreement and the development of PRX002 and other Licensed Products, including the ability of Prothena and Roche to successfully research, develop and commercialize antibodies that target alpha-synuclein (including PRX002), the ability of Prothena and Roche to obtain regulatory approval to manufacture, market and sell Licensed Products, including PRX002, in or outside of the United States, the efficacy of Licensed Products, including PRX002, as a treatment for Parkinson’s disease or other synucleinopathies, the ability for Prothena to achieve the milestones or receive royalties under the License Agreement in order to receive payments thereunder and the ability for the parties to satisfy all the conditions to effectiveness of the License Agreement, including HSR clearance. These forward-looking statements involve risks and uncertainties. Actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks and uncertainties described in Prothena’s SEC filings, including the “Risk Factors” section of Prothena’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Item 9.01.
Financial Statements and Exhibits.
(d)  Exhibits .
Exhibit No.
 
Description
99.1
 
Press Release dated December 11, 2013.



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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.

Date: December 11, 2013
PROTHENA CORPORATION PLC
 
 
 
 
 
By:
 
/s/ Dale B. Schenk
 
Name:
 
Dale B. Schenk
 
Title:
 
Chief Executive Officer


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EXHIBIT INDEX
 
Exhibit No.
 
Description
99.1
 
Press Release dated December 11, 2013.


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Exhibit 99.1

Roche and Prothena Enter into Worldwide Collaboration to Co-Develop and Co-Promote Antibodies for Treatment of Parkinson’s Disease
Prothena to receive up to $600 million, inclusive of upfront payment and near-term clinical milestone totaling $45 million, as well as 30 percent of U.S. profits, and up to double-digit royalties on ex-U.S. net sales
Prothena to host conference call/webcast today (December 11) at 4:30 p.m. Eastern Time

BASEL, Switzerland and DUBLIN, Ireland - December 11, 2013 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Prothena Corporation plc (NASDAQ:PRTA), announced today that they have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena’s monoclonal antibody for the treatment of Parkinson’s disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson’s disease in 2014.

Synuclein proteins are a family of charged proteins found throughout the body. One protein from this family, alpha-synuclein, is found extensively in neurons and is a major component of pathological inclusions that characterize several neurodegenerative disorders, including Parkinson's disease, dementia with Lewy bodies, neurodegeneration with brain iron accumulation type 1, and multiple system atrophy, which collectively are termed synucleinopathies.

“Parkinson's is a severely debilitating and progressive neurodegenerative disease that leads to both a gradual worsening of motor function and cognitive and behavioral alterations,” said Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche. “Currently, there is no treatment that modifies its course, and by targeting one of Parkinson’s key molecular determinants, PRX002 has the potential to slowdown or reduce its progression. This approach is consistent with our strategy in other neurodegenerative diseases, such as Alzheimer’s, Huntington, Multiple Sclerosis or Spinal Muscular Atrophy, where we target the molecular pathophysiology and intervene early with the objective to slowdown or halt the progression of disease.”

“We are excited to be working with Roche to develop PRX002 as a disease modifying treatment for Parkinson’s disease and potentially other synucleinopathies. Roche is a global leader in drug development with significant experience in developing drugs to treat neurological diseases,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. “By combining Roche’s expertise with our own, this collaboration will greatly enhance our development efforts with PRX002 and allow us to move forward in a more comprehensive manner. This collaboration also represents an important milestone in our growth as we continue to execute on our corporate strategy to be a leading fully-integrated biotechnology company.”

Roche and Prothena will collaborate on the development of PRX002 for Parkinson’s disease and potentially other synucleinopathies. Prothena also has an option to co-promote PRX002 in the U.S. In the U.S., the companies will share all development and commercialization costs, as well as profits, on a 70/30 basis (70% Roche and 30% Prothena). Outside the U.S., Roche will have sole responsibility for developing and commercializing PRX002 and will pay Prothena up to double-digit royalties on net sales.





Under the terms of the agreement, Prothena will receive an upfront payment and near-term clinical milestone totaling $45 million. Prothena is also eligible to receive additional payments of up to $380 million upon the achievement of development, regulatory and first commercial sales milestones plus up to an additional $175 million in ex-U.S. commercial milestone payments. The total worldwide upfront and milestone payments may amount up to $600 million.

Also as part of the agreement, Roche and Prothena will initiate a research collaboration focused on optimizing early stage antibodies targeting alpha-synuclein including incorporation of Roche’s proprietary Brain Shuttle™ technology to increase delivery of therapeutic antibodies to the brain.

The transaction is subject to customary regulatory clearances including expiration of the applicable Hart-Scott-Rodino waiting period. Prothena’s legal and financial advisers on the transaction were Latham & Watkins LLP and BioAsset Advisors, respectively.

Conference Call

Prothena will host a conference call this afternoon (December 11) at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement.

The conference call and live audio webcast can be accessed as follows:
Dial-in: 877-887-5215 (U.S. toll free) or 315-625-3069 (international)
Conference ID Number: 21227734
Webcast: http://ir.prothena.com

A replay of the webcast will be available for 30 days following the conference call date via dial-in to 855-859-2056 (U.S. toll free) or 404-537-3406 (international), Conference ID Number 21227734 , or via webcast on the investor relations section of Prothena's website at http://ir.prothena.com .

About Parkinson’s disease

Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease. There are an estimated seven to ten million patients with Parkinson’s disease worldwide. Current treatments for Parkinson’s disease are effective at managing the early motor symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms.

About PRX002

PRX002, a monoclonal antibody targeting alpha-synuclein, has been tested in various cellular and animal models of synuclein-related disease and has shown in multiple transgenic mouse models of Parkinson’s disease, that passive immunization with 9E4, the murine version of PRX002, reduced the appearance of synuclein pathology, protected synaptic connections and improved performance by the mice in behavioral testing. PRX002 may slow or reduce the neurodegeneration associated with synuclein misfolding and/or cell-to-cell transmission of pathogenic forms of synuclein.


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About Prothena

Prothena Corporation plc is a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of a broad range of diseases that involve protein misfolding and cell adhesion, particularly on the discovery, development and commercialization of potential therapeutic monoclonal antibodies directed specifically to disease-causing proteins. These potential therapies have a broad range of indications, including AL and AA forms of amyloidosis (NEOD001), Parkinson’s disease and related synucleinopathies (PRX002), and novel cell adhesion targets involved in inflammatory disease and metastatic cancers (PRX003). Prothena conducts its operations through its wholly-owned subsidiaries, Neotope Biosciences Limited, Onclave Therapeutic Limited and Prothena Biosciences Inc. For more information, please visit www.prothena.com .

About Roche Neuroscience

Roche is working on new molecular entities in neuroscience that could become the next generation of medicines for a range of diseases including schizophrenia, multiple sclerosis, depression, neurodevelopmental disorders, Parkinson’s disease and Alzheimer’s disease. With one of the strongest neuroscience pipelines in the industry, and by working closely with academic institutions, biotech companies, and forming public-private partnerships, Roche’s focus is on expanding its neuroscience franchise to better serve patients.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com .

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements relate to, among other things, the ability to maintain HSR compliance, the ability of Prothena and Roche to successfully research, develop and commercialize antibodies that target alpha-synuclein (including PRX002), the ability of Prothena and Roche to obtain regulatory approval to manufacture, market and sell PRX002 in or outside of the United States, the efficacy of PRX002 as a treatment for Parkinson’s disease or other synucleinopathies, the ability for Prothena to achieve milestones or receive royalties under the agreement in order to receive payments thereunder, and the expected timing of PRX002 clinical development, including Phase 1 clinical trials. These forward-looking statements are identified by their use of terms and phrases such as "anticipate," "believe," "could," "should," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "target," "will" and similar terms and phrases, including references to assumptions. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors including, but not limited to the risks and uncertainties described in Prothena’s SEC filings, including the "Risk Factors" section of Prothena’s Annual

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Report on Form 10-K and Quarterly Reports on Form 10-Q. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena's expectations.

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For further information:

Prothena
Investors:  Tran Nguyen, CFO
650-837-8535,  IR@prothena.com
Media:  Anita Kawatra
646-256-5116,  anita.kawatra@prothena.com

Roche Partnering
Emilie Vincent, Head of Roche Partnering Communications, emilie.vincent@roche.com


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